Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K900056 |
Device Name |
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE |
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 | 880.5200
|
Classification Product Code |
|
Date Received | 01/03/1990 |
Decision Date | 08/15/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|