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FDA 510(k)

Bio-Medicus Insertion Kit

K-Number: K190557 · 2019-04-03

ApplicantMedtronic, Inc.
Decision Date2019-04-03
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bio-Medicus Insertion Kit is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2019-04-03 under approval number K190557. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bio-Medicus Insertion Kit?

Bio-Medicus Insertion Kit is a medical device that received FDA 510(k) clearance on 2019-04-03. It is manufactured by Medtronic, Inc.. The 510(k) number is K190557.

When was Bio-Medicus Insertion Kit approved by the FDA?

Bio-Medicus Insertion Kit received FDA 510(k) clearance on 2019-04-03, under approval number K190557.

What company makes Bio-Medicus Insertion Kit?

Bio-Medicus Insertion Kit is manufactured by Medtronic, Inc..

What is the FDA product code for Bio-Medicus Insertion Kit?

The FDA product code for Bio-Medicus Insertion Kit is DWF.

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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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