Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K052081 |
Device Name |
REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA |
Applicant |
ESTECH, INC. |
1193 SHERMAN STREET |
ALAMEDA,
CA
94501
|
|
Applicant Contact |
CRAIG COOMBS |
Correspondent |
ESTECH, INC. |
1193 SHERMAN STREET |
ALAMEDA,
CA
94501
|
|
Correspondent Contact |
CRAIG COOMBS |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 08/02/2005 |
Decision Date | 12/16/2005 |
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
|
|
|