Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K022321 |
Device Name |
STOCKERT V172-28 VENOUS FEMORAL CANNULA |
Applicant |
STOCKERT INSTRUMENTE GMBH |
14401 W. 65th Way |
Arvada,
CO
80004 -3599
|
|
Applicant Contact |
SHAWN RIEDEL |
Correspondent |
STOCKERT INSTRUMENTE GMBH |
14401 W. 65th Way |
Arvada,
CO
80004 -3599
|
|
Correspondent Contact |
SHAWN RIEDEL |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 07/17/2002 |
Decision Date | 10/09/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|