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The Tracker / September 2026 / K262817

510(k) cleared

CrossFAST Integrated Microcatheter Advanced Delivery System

Vantis Vascular, Inc. · Sep 18, 2026 · K262817

FDA cleared the CrossFAST Integrated Microcatheter Advanced Delivery System from Vantis Vascular, Inc. on Sep 18, 2026 under K262817, a special 510(k). The device falls under product code DQY, Catheter, Percutaneous, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 7, 2026. The decision came 42 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Vantis Vascular, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262817?

K262817 is the FDA 510(k) for CrossFAST Integrated Microcatheter Advanced Delivery System, submitted by Vantis Vascular, Inc.. FDA's decision date was Sep 18, 2026, under product code DQY (Catheter, Percutaneous).

Who makes the CrossFAST Integrated Microcatheter Advanced Delivery System?

Vantis Vascular, Inc., based in San Jose, CA, is the applicant of record for K262817.

How long did the K262817 review take?

FDA received the submission on Aug 7, 2026 and issued its decision on Sep 18, 2026, 42 days later.

← All decisions in September 2026