Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K932141 |
Device Name |
CARDIAC CATHETERIZATION KIT |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Applicant Contact |
FREDERICK GUSTAFSON |
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent Contact |
FREDERICK GUSTAFSON |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 04/22/1993 |
Decision Date | 09/22/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|