Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K122937 |
Device Name |
SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) |
Applicant |
COOK, INC. |
750 DANIELS WAY |
Blmgtn,
IN
47404
|
|
Applicant Contact |
AMBER BROWN |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
Blmgtn,
IN
47404
|
|
Correspondent Contact |
AMBER BROWN |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 09/24/2012 |
Decision Date | 12/14/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|