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FDA 510(k)

CrossFAST Integrated Microcatheter Advanced Delivery System

K-Number: K262817 · 2026-09-18

ApplicantVantis Vascular, Inc.
Decision Date2026-09-18
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CrossFAST Integrated Microcatheter Advanced Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Vantis Vascular, Inc.. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K262817. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CrossFAST Integrated Microcatheter Advanced Delivery System?

CrossFAST Integrated Microcatheter Advanced Delivery System is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Vantis Vascular, Inc.. The 510(k) number is K262817.

When did CrossFAST Integrated Microcatheter Advanced Delivery System receive FDA 510(k) clearance?

CrossFAST Integrated Microcatheter Advanced Delivery System received FDA 510(k) clearance on 2026-09-18, under 510(k) number K262817.

Who is the listed applicant for CrossFAST Integrated Microcatheter Advanced Delivery System?

The FDA 510(k) record lists Vantis Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CrossFAST Integrated Microcatheter Advanced Delivery System?

The FDA product code for CrossFAST Integrated Microcatheter Advanced Delivery System is DQY.

Other records listing Vantis Vascular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242276CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)

Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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