FDA 510(k)

MODIFICATION TO: ARTHREX V-TAK

K-Number: K050634 · 2005-03-21

Decision Date2005-03-21

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: ARTHREX V-TAK is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2005-03-21 under 510(k) number K050634. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: ARTHREX V-TAK?

MODIFICATION TO: ARTHREX V-TAK is a medical device that received FDA 510(k) clearance on 2005-03-21. The listed applicant is Arthrex, Inc.. The 510(k) number is K050634.

When did MODIFICATION TO: ARTHREX V-TAK receive FDA 510(k) clearance?

MODIFICATION TO: ARTHREX V-TAK received FDA 510(k) clearance on 2005-03-21, under 510(k) number K050634.

Who is the listed applicant for MODIFICATION TO: ARTHREX V-TAK?

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

What is the FDA product code for MODIFICATION TO: ARTHREX V-TAK?

The FDA product code for MODIFICATION TO: ARTHREX V-TAK is HWC. This falls under the Cardiovascular category.

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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.