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FDA 510(k)

Bio-Medicus Life Support Catheter and Introducer

K-Number: K201057 · 2022-01-14

ApplicantMedtronic, Inc.
Decision Date2022-01-14
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 2022-01-14 under approval number K201057. 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 2022-01-14. It is manufactured by Medtronic, Inc.. The 510(k) number is K201057.

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 2022-01-14, under approval number K201057.

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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Related Devices (Code: QHW)

K240534Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc. K251831Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.

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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