Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K861790 |
Device Name |
RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT |
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 | 05/09/1986 |
Decision Date | 07/21/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|