Vantis Vascular Wins FDA Clearance for 6F CrossFAST

Vantis Vascular has won FDA 510(k) clearance for a 6 French model of CrossFAST, the dual-monorail microcatheter delivery system the San Jose, California company has sold in a 5.5F size since January 2025. The company announced the clearance on 13 October 2026; its release does not state a K-number, and FDA's public 510(k) database has not yet indexed one for this submission. The larger lumen is built to carry a broader range of interventional devices, including intravascular ultrasound (IVUS) and intravascular lithotripsy (IVL) catheters, through complex percutaneous coronary intervention (PCI) cases the narrower 5.5F device could not accommodate. Both sizes are set to go on sale together in November 2026.

Two catheters that move as one

Vantis Vascular built CrossFAST around what it calls DuoPRO interlocking technology: an inner monorail microcatheter locks to an outer delivery catheter so the pair advances through the coronary or peripheral vasculature as a single unit, rather than as a guide catheter and a separate guide-extension catheter working independently. The company describes the result as the first and only dual-monorail microcatheter advanced delivery system built specifically for complex coronary and peripheral interventions — its own characterization, not an independent ranking. A retrospective case series published in the Journal of the Society for Cardiovascular Angiography & Interventions in 2026 (Yang, Saltiel, Fischell and Teirstein) reports that the device reached and crossed the target lesion in four complex PCI cases after conventional attempts, including with guide-extension catheters, had already failed.

A lumen built for IVUS and IVL

The original CrossFAST shipped at 5.5F, a size that reporting on the device’s early clinical use flagged as too narrow for some larger stents and for Shockwave’s intravascular lithotripsy (IVL) catheters. The new 6F model answers that directly: Vantis Vascular’s 13 October 2026 release says its larger lumen is designed to accommodate a broader range of interventional devices, including intravascular ultrasound (IVUS) and intravascular lithotripsy, and that the model carries a shorter distal tip for complex PCI. The two sizes share the same DuoPRO mechanism and the same FDA product code (DQY, percutaneous catheter) as the original clearance, which suggests a line extension rather than a new device architecture — though FDA's public record does not itself break out which design changes between the submissions it reviewed.

Three reasons the 6F lumen matters

01

A wider lumen, not a new catheter

The 6F model reuses CrossFAST’s DuoPRO dual-monorail mechanism and FDA product code (DQY) rather than introducing new mechanics — a line extension of a device already on the market since January 2025, not a ground-up redesign.

02

Built for IVUS and IVL together

The larger lumen is sized specifically for imaging (IVUS) and lithotripsy (IVL) catheters that the company's own published case series says the narrower 5.5F could not reliably carry alongside a stent delivery system.

03

Two sizes, sold side by side

Rather than replacing the 5.5F, Vantis Vascular plans to sell both sizes together from November 2026 — giving a cath lab a choice of lumen under one delivery platform instead of one fixed size.

CrossFAST's two sizes, in four numbers

6Fnew CrossFAST model FDA-cleared and announced 13 Oct 2026; K-number not yet indexed

5.5Foriginal CrossFAST size, cleared 30 Sep 2024 under K242276, on the U.S. market since January 2025

10complex coronary cases in CrossFAST's first commercial use; the company reported 100% procedural success

$15Mcombined SAFE (May 2024) and Series B-1 (Dec 2024) financing Vantis Vascular has disclosed to fund U.S. commercialization

Figures from Vantis Vascular's FDA submissions and its own announcements, 2024–2026.

The same product code as the 5.5F predicate

FDA's public 510(k) database does not yet list a K-number for the 6F submission; Vantis Vascular's own release does not state one either, so this article treats it as pending rather than printing a figure it cannot confirm. What is confirmed is the predicate: the original 5.5F CrossFAST cleared under K242276, filed by Vantis Vascular, Inc. under product code DQY (regulation 870.1250, percutaneous catheter), decided substantially equivalent on 30 September 2024 and announced on 25 October 2024 — a roughly three-and-a-half-week gap between FDA's letter and the company's release. Vantis Vascular's 13 October 2026 release describes the 6F model as built on the same CrossFAST platform, which is why this article expects, but cannot yet confirm, a K-number under the same product code once FDA's database catches up.

“The new CrossFAST model represents an important expansion of technology designed around the needs of interventional cardiologists.” Jason Turner, Chief Executive Officer, Vantis Vascular — 13 October 2026 announcement

A crowded shelf of fixed-diameter catheters

CrossFAST is not entering an empty category. Interventional cardiologists already reach for guide-extension catheters such as Teleflex's GuideLiner V3 and Telescope and Boston Scientific's Guidezilla II when a guide catheter alone cannot deliver a device to a distal or heavily calcified lesion, and for low-profile microcatheters such as Asahi Intecc's Corsair Pro to cross a lesion before a larger device follows. All four are FDA-cleared and commercially available today. Vantis Vascular's pitch is that CrossFAST's dual-monorail mechanism, rather than a fixed-diameter extension tube, is what lets one system now span two lumen sizes — 5.5F and 6F — without a reader needing a wholly different catheter for each.

CrossFAST against four fixed-diameter rivals

Product	Design	Sizes	IVUS/IVL through the same device	FDA status
CrossFAST (Vantis Vascular)	Dual-monorail microcatheter + outer delivery catheter (DuoPRO)	5.5F and 6F	Yes, at 6F	6F cleared Oct 2026 (K# pending); 5.5F cleared 2024 (K242276)
GuideLiner V3 (Teleflex)	Rapid-exchange guide-extension catheter	6F–8F	At larger sizes only, per Teleflex's own comparisons	Cleared, on market
Guidezilla II (Boston Scientific)	Guide-extension catheter, push-rod design similar to GuideLiner	6F–8F	At larger sizes only	Cleared, on market
Telescope (Teleflex)	Guide-extension catheter with a solid stainless-steel pushrod	6F–8F	At larger sizes only	Cleared, on market
Corsair Pro (Asahi Intecc)	Low-profile crossing microcatheter, not a guide extension	Under 3F outer diameter	No — built to cross, not to deliver IVUS/IVL	Cleared, on market

From each company's own labelling, bench-test materials and FDA 510(k) records; not a clinical comparison. Never a complete list of guide-extension or crossing microcatheters on the market.

Two ways to size this market

Published researchers do not agree on how to draw the boundary around CrossFAST's category, which spans both the narrow “micro guide catheter” segment and the broader cardiovascular microcatheter market. The two readings below differ by more than double for the same year, which says more about scope definitions than about the underlying demand.

Two sizes, two market readings

$538M → $1.63B

Two overlapping ways researchers size CrossFAST's category: micro guide catheters (Research and Markets, 2026–2034) and cardiovascular microcatheters (The Business Research Company, 2026–2030).

2026 micro guide catheters$538.5M

2034 micro guide catheters$864.8M

2026 cardiovascular microcatheters$1.17B

2030 cardiovascular microcatheters$1.63B

Sources: Research and Markets, Micro Guide Catheter Market Outlook 2026–2034 · The Business Research Company, Cardiovascular Microcatheter Market Report 2026 (via Research and Markets)

Regulatory News outlook

We expect the cardiovascular-microcatheter category CrossFAST's 6F model competes in to be worth roughly $1.4 billion a year by 2028, as more complex-PCI labs add IVUS and intravascular lithotripsy to cases that used to run through a fixed-diameter guide-extension catheter alone.

How we got here: Compounding The Business Research Company's $1.17 billion 2026 cardiovascular-microcatheter estimate at its own published 8.7% annual growth rate for two years (1.17 × 1.087²) reaches approximately $1.38 billion by 2028.

CrossLiner to Vantis, in eight years

Eight years, two clearances, one catheter

1. 2018

   Founded as CrossLiner

   Founded in San Jose, California, by physician co-founders including cardiologist Tim Fischell, MD, to build a next-generation guide-extension catheter; later renamed Vantis Vascular.

2. 21 May 2024

   $5M SAFE financing

   Closed a $5 million SAFE round to fund CrossFAST's commercial launch and accelerate development of CrossShock, the company's intravascular lithotripsy (IVL) system still in development.

3. 30 September 2024

   Original CrossFAST cleared

   FDA 510(k) clearance (K242276) for the 5.5F CrossFAST Integrated Microcatheter Guide Extension System, product code DQY; announced 25 October 2024.

4. 12 December 2024

   $10M Series B-1

   Closed a $10 million Series B-1 preferred round earmarked for starting U.S. commercialization of CrossFAST.

5. January 2025

   First commercial case

   Dr. Amir Kaki performed the first commercial CrossFAST case at St. John's Hospital in Detroit, Michigan.

6. 23 January 2025

   Ten cases, 100% success

   Vantis Vascular reported 100% procedural success across CrossFAST's first ten complex, high-risk coronary cases.

7. 13 October 2026

   6F clearance announced

   Vantis Vascular announces FDA 510(k) clearance for the 6F CrossFAST model, built for a broader range of interventional devices including IVUS and IVL; the K-number is not yet indexed in FDA's public database.

8. November 2026

   Both sizes on sale

   The 6F model becomes commercially available alongside the existing 5.5F model.

November's two-model lineup

What happens next is mostly logistics: Vantis Vascular says both CrossFAST sizes will be commercially available together in November 2026, giving cath labs a 5.5F option with roughly two years of real-world use behind it and a 6F option sized for IVUS and IVL cases that are becoming more common in complex PCI. The company has not disclosed pricing, distribution terms or a sales-force size for the dual-size launch, and CrossShock, its intravascular lithotripsy system, remains in development and is not yet FDA-cleared or named in either CrossFAST submission.

• Commercial availability: November 2026, both the 6F and 5.5F CrossFAST models sold side by side.
• CrossShock: Vantis Vascular's separate intravascular lithotripsy (IVL) system remains in development; it is not FDA-cleared and is not part of either CrossFAST clearance.
• Funding: the company has disclosed a $5 million SAFE (May 2024) and a $10 million Series B-1 preferred round (December 2024) — $15 million combined; third-party funding trackers report inconsistent cumulative totals (roughly $24 million to $30 million) that Vantis Vascular has not publicly reconciled.
• Independent corroboration: as of publication, trade coverage of the 6F clearance consists of wire syndication of Vantis Vascular's own release; we are not aware of independent trade-press reporting on the 6F model specifically beyond FDA's own 510(k) record and the company's prior, peer-reviewed case series on the 5.5F device.

Frequently asked questions

What did FDA clear for Vantis Vascular?

A 510(k) clearance, announced 13 October 2026, for a 6 French (6F) model of the CrossFAST Integrated Microcatheter Advanced Delivery System. The company's release does not name a K-number, and FDA's public 510(k) database has not yet indexed one for this submission as of publication. The 6F model's larger lumen is built to accommodate a broader range of interventional devices, including intravascular ultrasound (IVUS) and intravascular lithotripsy (IVL), with a shorter distal tip for complex percutaneous coronary intervention (PCI).

How is the 6F model different from the original CrossFAST?

The original CrossFAST is a 5.5F device, cleared under K242276 (decided 30 September 2024) and commercially available in the U.S. since January 2025. Both sizes use the same DuoPRO interlocking mechanism, which couples an inner monorail microcatheter to an outer delivery catheter so they advance as one unit. The 6F model's wider lumen is what newly allows IVUS and IVL catheters through the system; the two sizes are set to be sold side by side starting November 2026.

Is Vantis Vascular a public company?

No. Vantis Vascular, Inc. is privately held, based in San Jose, California, and founded in 2018 (originally as CrossLiner) by physician co-founders including cardiologist Tim Fischell, MD. It has disclosed a $5 million SAFE round (May 2024) and a $10 million Series B-1 preferred round (December 2024); third-party trackers report inconsistent cumulative totals that the company has not publicly reconciled.

What else competes with CrossFAST?

Guide-extension catheters already on the market include Teleflex's GuideLiner V3 and Telescope and Boston Scientific's Guidezilla II; Asahi Intecc's Corsair Pro is a low-profile microcatheter used for crossing rather than device delivery. All are FDA-cleared and commercially available; CrossFAST is the newer entrant, and the only one of these sold at both a 5.5F and a 6F size point, per the sources cited in this article.