Device Classification Name |
Apparatus, Autotransfusion
|
510(k) Number |
K053000 |
Device Name |
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) |
Applicant |
HAEMONETICS CORP. |
400 WOOD ROAD |
BRAINTREE,
MA
02184 -9114
|
|
Applicant Contact |
GABRIEL J MURACA |
Correspondent |
HAEMONETICS CORP. |
400 WOOD ROAD |
BRAINTREE,
MA
02184 -9114
|
|
Correspondent Contact |
GABRIEL J MURACA |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 10/25/2005 |
Decision Date | 11/21/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|