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FDA 510(k)

VALVULOTOME BY KOVEN

K-Number: K080178 · 2008-07-28

ApplicantKoven Technology, Inc.
Decision Date2008-07-28
Product CodeMGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VALVULOTOME BY KOVEN is the device name listed in this FDA 510(k) record. The listed applicant is Koven Technology, Inc.. It received FDA 510(k) clearance on 2008-07-28 under 510(k) number K080178. The device is classified under product code MGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALVULOTOME BY KOVEN?

VALVULOTOME BY KOVEN is a medical device that received FDA 510(k) clearance on 2008-07-28. The listed applicant is Koven Technology, Inc.. The 510(k) number is K080178.

When did VALVULOTOME BY KOVEN receive FDA 510(k) clearance?

VALVULOTOME BY KOVEN received FDA 510(k) clearance on 2008-07-28, under 510(k) number K080178.

Who is the listed applicant for VALVULOTOME BY KOVEN?

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

What is the FDA product code for VALVULOTOME BY KOVEN?

The FDA product code for VALVULOTOME BY KOVEN is MGZ.

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Other records listing Koven Technology, Inc. as applicant

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Related Devices (Code: MGZ)

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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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