Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K012617 |
Device Name |
JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... |
Applicant |
JOSTRA AG |
P.O. BOX 218 |
OXFORD,
PA
19363
|
|
Applicant Contact |
KATHLEEN JOHNSON |
Correspondent |
JOSTRA AG |
P.O. BOX 218 |
OXFORD,
PA
19363
|
|
Correspondent Contact |
KATHLEEN JOHNSON |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 08/13/2001 |
Decision Date | 11/06/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|