Wexler Vascular Clamp Series

FDA 510(k) K110148 · Microsurgical Laboratories,Inc.Dba Wexler Surgical

Substantially Equivalent

510(k) numberK110148

Submission

Device name
Wexler Vascular Clamp Series
Applicant
Microsurgical Laboratories,Inc.Dba Wexler Surgical
Bellaire, TX, US
Received
January 18, 2011
Decision date
April 19, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DXC – Clamp, Vascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4450
Specialty
Cardiovascular

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More from Vascular Graft Solutions, Ltd.

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K110121Wexler Endoscope AccessoriesGCJ · Traditional 05/10/2011SE
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Questions and answers

When was Wexler Vascular Clamp Series cleared by the FDA?

Wexler Vascular Clamp Series (K110148) received a 510(k) decision of Substantially Equivalent on April 19, 2011, 91 days after the submission was received.

What is the product code of K110148?

The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.