| 510(k) Number |
K851495 |
| Device Name |
THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY |
| Applicant |
| Thoratec Laboratories Corp. |
| 2023 Eighth St. |
|
Berkeley,
CA
94710
|
|
| Applicant Contact |
KARL HALL |
| Correspondent |
| Thoratec Laboratories Corp. |
| 2023 Eighth St. |
|
Berkeley,
CA
94710
|
|
| Correspondent Contact |
KARL HALL |
| Date Received | 04/15/1985 |
| Decision Date | 08/01/1985 |
| Decision |
Substantially Equivalent - With Drug
(SESD) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|