Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K891576 |
Device Name |
FEM-FLEX FEMORAL ACCESS CANNULATION SET |
Applicant |
RESEARCH MEDICAL, INC. |
1847 WEST 2300 SOUTH |
SALT LAKE CITY,
UT
84119
|
|
Applicant Contact |
MICHAEL N KELLY |
Correspondent |
RESEARCH MEDICAL, INC. |
1847 WEST 2300 SOUTH |
SALT LAKE CITY,
UT
84119
|
|
Correspondent Contact |
MICHAEL N KELLY |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 03/20/1989 |
Decision Date | 10/12/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|