FDA 510(k)

SENDERO MAX Delivery Catheter

K-Number: K242644 · 2024-12-20

Decision Date2024-12-20

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SENDERO MAX Delivery Catheter is a medical device manufactured by Okami Medical, Inc.. It received FDA 510(k) clearance on 2024-12-20 under approval number K242644. 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 MAX Delivery Catheter?

SENDERO MAX Delivery Catheter is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by Okami Medical, Inc.. The 510(k) number is K242644.

When was SENDERO MAX Delivery Catheter approved by the FDA?

SENDERO MAX Delivery Catheter received FDA 510(k) clearance on 2024-12-20, under approval number K242644.

What company makes SENDERO MAX Delivery Catheter?

SENDERO MAX Delivery Catheter is manufactured by Okami Medical, Inc..

What is the FDA product code for SENDERO MAX Delivery Catheter?

The FDA product code for SENDERO MAX Delivery Catheter is DQY.

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Other Devices by Okami Medical, Inc.

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Related Devices (Code: DQY)

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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.