Cleared Traditional

K024008 - SMALL BARD VENTRALEX PATCH (FDA 510(k) Clearance)

K024008 · C.R. Bard, Inc. · General & Plastic Surgery device

Feb 2003

Decision

78d

Days

Class 2

Risk

K024008 is an FDA 510(k) clearance for the SMALL BARD VENTRALEX PATCH. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).

Submitted by C.R. Bard, Inc. (Cranston, US). The FDA issued a Cleared decision on February 20, 2003, 78 days after receiving the submission on December 4, 2002.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K024008 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 04, 2002
Decision Date	February 20, 2003
Days to Decision	78 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF