FDA 510(k)

Bio-Medicus Adult Cannulae Kit

K-Number: K180456 · 2018-03-22

Decision Date2018-03-22

Product CodeDWF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Bio-Medicus Adult Cannulae 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 2018-03-22 under 510(k) number K180456. 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 Adult Cannulae Kit?

Bio-Medicus Adult Cannulae Kit is a medical device that received FDA 510(k) clearance on 2018-03-22. The listed applicant is Medtronic, Inc.. The 510(k) number is K180456.

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

Bio-Medicus Adult Cannulae Kit received FDA 510(k) clearance on 2018-03-22, under 510(k) number K180456.

Who is the listed applicant for Bio-Medicus Adult Cannulae 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 Adult Cannulae Kit?

The FDA product code for Bio-Medicus Adult Cannulae 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.