Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K913682 |
Device Name |
MERIT CUSTOM KIT |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
79 WEST 4500 SOUTH |
SUITE 9 |
SALT LAKE CITY,
UT
84107
|
|
Applicant Contact |
DENNIS REIGLE |
Correspondent |
MERIT MEDICAL SYSTEMS, INC. |
79 WEST 4500 SOUTH |
SUITE 9 |
SALT LAKE CITY,
UT
84107
|
|
Correspondent Contact |
DENNIS REIGLE |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 08/19/1991 |
Decision Date | 11/15/1991 |
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
|
|
|