Device Classification Name |
system, balloon, intra-aortic and control
|
510(k) Number |
K010330 |
Device Name |
ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U |
Applicant |
ARROW INTL., INC. |
9 PLYMOUTH ST. |
EVERETT,
MA
02149
|
|
Applicant Contact |
WILLIAM PAQUIN |
Correspondent |
ARROW INTL., INC. |
9 PLYMOUTH ST. |
EVERETT,
MA
02149
|
|
Correspondent Contact |
WILLIAM PAQUIN |
Regulation Number | 870.3535
|
Classification Product Code |
|
Date Received | 02/02/2001 |
Decision Date | 03/02/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|