Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K993818 |
Device Name |
ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE |
Applicant |
CALIFORNIA MEDICAL LABORATORIES, INC. |
2681 KELVIN AVE. |
IRVINE,
CA
92614
|
|
Applicant Contact |
MEHMET BICAKCI |
Correspondent |
CALIFORNIA MEDICAL LABORATORIES, INC. |
2681 KELVIN AVE. |
IRVINE,
CA
92614
|
|
Correspondent Contact |
MEHMET BICAKCI |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 11/10/1999 |
Decision Date | 02/08/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|