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FDA 510(k)

CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)

K-Number: K242276 · 2024-09-30

ApplicantVantis Vascular, Inc.
Decision Date2024-09-30
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) is a medical device manufactured by Vantis Vascular, Inc.. It received FDA 510(k) clearance on 2024-09-30 under approval number K242276. 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 Guide Extension System (CFM55)?

CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) is a medical device that received FDA 510(k) clearance on 2024-09-30. It is manufactured by Vantis Vascular, Inc.. The 510(k) number is K242276.

When was CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) approved by the FDA?

CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) received FDA 510(k) clearance on 2024-09-30, under approval number K242276.

What company makes CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)?

CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) is manufactured by Vantis Vascular, Inc..

What is the FDA product code for CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)?

The FDA product code for CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) is DQY.

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Related PubMed Literature

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Related Devices (Code: DQY)

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Official Source

View on FDA Database →

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

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