FDA 510(k)

Bio-Medicus Insertion Kit

K-Number: K190557 · 2019-04-03

Decision Date2019-04-03

Product CodeDWF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Bio-Medicus Insertion Kit is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2019-04-03 under 510(k) 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. The listed applicant is Medtronic, Inc.. The 510(k) number is K190557.

When did Bio-Medicus Insertion Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Bio-Medicus Insertion Kit?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.