Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K901452 |
Device Name |
USCI(R) ACCESS(TM) INTRODUCER SET |
Applicant |
C.R. BARD, INC. |
ONE PARK WEST |
TEWKSBURY,
MA
01876 -1234
|
|
Applicant Contact |
ANNE M KULIS |
Correspondent |
C.R. BARD, INC. |
ONE PARK WEST |
TEWKSBURY,
MA
01876 -1234
|
|
Correspondent Contact |
ANNE M KULIS |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/28/1990 |
Decision Date | 05/22/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|