Device Classification Name |
Device, Percutaneous Retrieval
|
510(k) Number |
K112185 |
Device Name |
FOURSNARE VASCULAR RETRIEVAL SNARE |
Applicant |
COOK, INC. |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Applicant Contact |
MOLLY BUSENBARK |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Correspondent Contact |
MOLLY BUSENBARK |
Regulation Number | 870.5150
|
Classification Product Code |
|
Date Received | 07/29/2011 |
Decision Date | 11/02/2011 |
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
|
|
|