Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K132592 |
Device Name |
FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET |
Applicant |
COOK, INC. |
750 DANIELS WAY |
Blmgtn,
IN
47404
|
|
Applicant Contact |
DAVID LEHR |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
Blmgtn,
IN
47404
|
|
Correspondent Contact |
DAVID LEHR |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 08/19/2013 |
Decision Date | 10/09/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|