Device Classification Name |
catheter, intravascular, therapeutic, long-term greater than 30 days
|
510(k) Number |
K133634 |
Device Name |
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET |
Applicant |
COOK, INC. |
750 DANIELS WAY |
Blmgtn,
IN
47404
|
|
Applicant Contact |
SEAN SPENCE |
Correspondent |
COOK, INC. |
750 DANIELS WAY |
Blmgtn,
IN
47404
|
|
Correspondent Contact |
SEAN SPENCE |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 11/26/2013 |
Decision Date | 12/23/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|