Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K964248 |
Device Name |
HEARTPORT ENDOCORONARY SINUS CATHETR |
Applicant |
HEARTPORT, INC. |
200 CHESAPEAKE DR. |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
KEVIN F MACDONALD |
Correspondent |
HEARTPORT, INC. |
200 CHESAPEAKE DR. |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
KEVIN F MACDONALD |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 10/24/1996 |
Decision Date | 01/22/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|