Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K020693 |
Device Name |
AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101 |
Applicant |
EMBOL-X, INC. |
645 CLYDE AVE. |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
EDWIN LEE |
Correspondent |
EMBOL-X, INC. |
645 CLYDE AVE. |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
EDWIN LEE |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 03/04/2002 |
Decision Date | 09/05/2002 |
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
|
|
|