Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K023880 |
Device Name |
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER |
Applicant |
ETHICON, INC. |
P.O BOX 151, ROUTE 22 WEST |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
PETER CECCHINI |
Correspondent |
ETHICON, INC. |
P.O BOX 151, ROUTE 22 WEST |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
PETER CECCHINI |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 11/21/2002 |
Decision Date | 12/11/2002 |
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
|
|
|