Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K961270 |
Device Name |
HEARTPORT ENDOSINUS CATHETER |
Applicant |
HEARTPORT, INC. |
200 CHESAPEAKE DR. |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
ROBERT J CHIN |
Correspondent |
HEARTPORT, INC. |
200 CHESAPEAKE DR. |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
ROBERT J CHIN |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 04/02/1996 |
Decision Date | 06/18/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|