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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 the device name listed in this FDA 510(k) record. The listed applicant is Kapp Surgical Instrument, Inc.. It received FDA 510(k) clearance on 2021-01-28 under 510(k) 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. The listed applicant is Kapp Surgical Instrument, Inc.. The 510(k) number is K200289.

When did Michler-Kapp Cardiovascular Vent Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Michler-Kapp Cardiovascular Vent Catheter?

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

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

The FDA product code for Michler-Kapp Cardiovascular Vent Catheter is DWF.

Related Devices (Code: DWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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