| Device Classification Name |
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
More FDA Info for this Device |
| 510(K) Number |
K020233 |
| Device Name |
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant |
CHASE MEDICAL, INC.
1710 FIRMAN DR.
SUITE 100
RICHARDSON, TX 75081 US
Other 510(k) Applications for this Company
|
| Contact |
DAVE HERNON
Other 510(k) Applications for this Contact |
| Regulation Number |
870.3470
More FDA Info for this Regulation Number |
| Classification Product Code |
DXZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
01/23/2002 |
| Decision Date |
03/14/2002 |
| Decision |
SESE - SUBST EQUIV |
| Classification Advisory Committee |
CV - Cardiovascular |
| Review Advisory Committee |
CV - Cardiovascular |
| Statement / Summary / Purged Status |
Statement |
| Type |
Traditional |
| Reviewed By Third Party |
N |
| Expedited Review |
|