Device Classification Name |
system, balloon, intra-aortic and control
|
510(k) Number |
K965209 |
Device Name |
ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) |
Applicant |
ARROW INTL., INC. |
9 PLYMOUTH ST. |
EVERETT,
MA
02149
|
|
Applicant Contact |
MICHAEL JESI |
Correspondent |
ARROW INTL., INC. |
9 PLYMOUTH ST. |
EVERETT,
MA
02149
|
|
Correspondent Contact |
MICHAEL JESI |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 12/27/1996 |
Decision Date | 01/23/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|