| Device Classification Name |
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
More FDA Info for this Device |
| 510(K) Number |
K953564 |
| Device Name |
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant |
MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
4633 EAST LA PALMA AVE.
ANAHEIM, CA 92807 US
Other 510(k) Applications for this Company
|
| Contact |
WAYNE R HOHMAN
Other 510(k) Applications for this Contact |
| Regulation Number |
870.4290
More FDA Info for this Regulation Number |
| Classification Product Code |
DTL
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
07/31/1995 |
| Decision Date |
02/02/1996 |
| Decision |
SESE - SUBST EQUIV |
| Classification Advisory Committee |
CV - Cardiovascular |
| Review Advisory Committee |
CV - Cardiovascular |
| Statement / Summary / Purged Status |
Summary |
| Type |
Traditional |
| Reviewed By Third Party |
N |
| Expedited Review |
|