Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K133114 |
Device Name |
MICROPUNCTURE INTRODUCER SET |
Applicant |
COOK INCORPORATED |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Applicant Contact |
DAVID LEHR, RAC |
Correspondent |
COOK INCORPORATED |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Correspondent Contact |
DAVID LEHR, RAC |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 09/30/2013 |
Decision Date | 07/03/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|