Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K014303 |
Device Name |
JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE |
Applicant |
JOSTRA AG |
478 MEDIA RD. |
OXFORD,
PA
19363
|
|
Applicant Contact |
KATHLEEN JOHNSON |
Correspondent |
JOSTRA AG |
478 MEDIA RD. |
OXFORD,
PA
19363
|
|
Correspondent Contact |
KATHLEEN JOHNSON |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 12/31/2001 |
Decision Date | 03/26/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|