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FDA 510(k)

SENDERO Microcatheter

K-Number: K231600 · 2023-11-17

Decision Date2023-11-17
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENDERO Microcatheter is a medical device manufactured by Okami Medical, Inc.. It received FDA 510(k) clearance on 2023-11-17 under approval number K231600. 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 SENDERO Microcatheter?

SENDERO Microcatheter is a medical device that received FDA 510(k) clearance on 2023-11-17. It is manufactured by Okami Medical, Inc.. The 510(k) number is K231600.

When was SENDERO Microcatheter approved by the FDA?

SENDERO Microcatheter received FDA 510(k) clearance on 2023-11-17, under approval number K231600.

What company makes SENDERO Microcatheter?

SENDERO Microcatheter is manufactured by Okami Medical, Inc..

What is the FDA product code for SENDERO Microcatheter?

The FDA product code for SENDERO Microcatheter is DQY.

Other Devices by Okami Medical, Inc.

Related Devices (Code: DQY)

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.