Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K961552 |
Device Name |
CVP POLYURETHANE CATHETER |
Applicant |
ABBOTT LABORATORIES |
DEPT. 389, AP30 |
ABBOTT PARK,
IL
60064 -3537
|
|
Applicant Contact |
DAVID GUZEK |
Correspondent |
ABBOTT LABORATORIES |
DEPT. 389, AP30 |
ABBOTT PARK,
IL
60064 -3537
|
|
Correspondent Contact |
DAVID GUZEK |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 04/22/1996 |
Decision Date | 02/10/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|