Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K011217 |
Device Name |
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT |
Applicant |
ABBOTT LABORATORIES |
DEPT. 389, AP30 |
200 ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3537
|
|
Applicant Contact |
THOMAS P SAMPOGNA |
Correspondent |
ABBOTT LABORATORIES |
DEPT. 389, AP30 |
200 ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3537
|
|
Correspondent Contact |
THOMAS P SAMPOGNA |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 04/20/2001 |
Decision Date | 05/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|