Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K994243 |
Device Name |
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP |
Applicant |
HEARTPORT, INC. |
700 BAY RD. |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
MARIANNE C DRENNAN |
Correspondent |
HEARTPORT, INC. |
700 BAY RD. |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
MARIANNE C DRENNAN |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 12/16/1999 |
Decision Date | 05/05/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|