Cleared Traditional

K021129 - CHARE CARIOVASCULAR PATCH
(FDA 510(k) Clearance)

K021129 · Chase Medical, Inc. · Cardiovascular

Jun 2002

Decision

56d

Days

Class 2

Risk

K021129 is an FDA 510(k) clearance for the CHARE CARIOVASCULAR PATCH, a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ), submitted by Chase Medical, Inc. (Richardson, US). The FDA issued a Cleared decision on June 3, 2002, 56 days after receiving the submission on April 8, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number	K021129 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2002
Decision Date	June 03, 2002
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement