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FDA 510(k)

Michler-Kapp Cardiovascular Vent Catheter

K-Number: K200289 · 2021-01-28

ApplicantKapp Surgical Instrument, Inc.
Decision Date2021-01-28
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Michler-Kapp Cardiovascular Vent Catheter is a medical device manufactured by Kapp Surgical Instrument, Inc.. It received FDA 510(k) clearance on 2021-01-28 under approval number K200289. 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 Michler-Kapp Cardiovascular Vent Catheter?

Michler-Kapp Cardiovascular Vent Catheter is a medical device that received FDA 510(k) clearance on 2021-01-28. It is manufactured by Kapp Surgical Instrument, Inc.. The 510(k) number is K200289.

When was Michler-Kapp Cardiovascular Vent Catheter approved by the FDA?

Michler-Kapp Cardiovascular Vent Catheter received FDA 510(k) clearance on 2021-01-28, under approval number K200289.

What company makes Michler-Kapp Cardiovascular Vent Catheter?

Michler-Kapp Cardiovascular Vent Catheter is manufactured by Kapp Surgical Instrument, Inc..

What is the FDA product code for Michler-Kapp Cardiovascular Vent Catheter?

The FDA product code for Michler-Kapp Cardiovascular Vent Catheter 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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