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FDA 510(k)

CoraForce Microcatheter, CoraFlex Microcatheter

K-Number: K251277 · 2025-08-22

ApplicantReflow Medical, Inc.
Decision Date2025-08-22
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CoraForce Microcatheter, CoraFlex Microcatheter is a medical device manufactured by Reflow Medical, Inc.. It received FDA 510(k) clearance on 2025-08-22 under approval number K251277. 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 CoraForce Microcatheter, CoraFlex Microcatheter?

CoraForce Microcatheter, CoraFlex Microcatheter is a medical device that received FDA 510(k) clearance on 2025-08-22. It is manufactured by Reflow Medical, Inc.. The 510(k) number is K251277.

When was CoraForce Microcatheter, CoraFlex Microcatheter approved by the FDA?

CoraForce Microcatheter, CoraFlex Microcatheter received FDA 510(k) clearance on 2025-08-22, under approval number K251277.

What company makes CoraForce Microcatheter, CoraFlex Microcatheter?

CoraForce Microcatheter, CoraFlex Microcatheter is manufactured by Reflow Medical, Inc..

What is the FDA product code for CoraForce Microcatheter, CoraFlex Microcatheter?

The FDA product code for CoraForce Microcatheter, CoraFlex Microcatheter is 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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