CHARE CARIOVASCULAR PATCH


Device Classification Name

patch, pledget and intracardiac, petp, ptfe, polypropylene

510(k) Number K021129
Device Name CHARE CARIOVASCULAR PATCH
Original Applicant
CHASE MEDICAL, INC.
1710 firman dr.
suite 100
richardson, 
TX 
75081

Original Contact dave hernon
Regulation Number 870.3470
Classification Product Code
DXZ  
Date Received 04/08/2002
Decision Date 06/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No