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FDA 510(k)

Bio-Medicus Life Support Catheter and Introducer

K-Number: K240534 · 2024-04-19

Decision Date2024-04-19
Product CodeQHW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bio-Medicus Life Support Catheter and Introducer is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2024-04-19 under approval number K240534. The device is classified under product code QHW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bio-Medicus Life Support Catheter and Introducer?

Bio-Medicus Life Support Catheter and Introducer is a medical device that received FDA 510(k) clearance on 2024-04-19. It is manufactured by Medtronic, Inc.. The 510(k) number is K240534.

When was Bio-Medicus Life Support Catheter and Introducer approved by the FDA?

Bio-Medicus Life Support Catheter and Introducer received FDA 510(k) clearance on 2024-04-19, under approval number K240534.

What company makes Bio-Medicus Life Support Catheter and Introducer?

Bio-Medicus Life Support Catheter and Introducer is manufactured by Medtronic, Inc..

What is the FDA product code for Bio-Medicus Life Support Catheter and Introducer?

The FDA product code for Bio-Medicus Life Support Catheter and Introducer is QHW.

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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.