Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K082613 |
Device Name |
MERIT MICROCATHETER |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. |
SOUTH JORDAN,
UT
84095
|
|
Applicant Contact |
MICHAELA RIVKOWICH |
Correspondent |
MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. |
SOUTH JORDAN,
UT
84095
|
|
Correspondent Contact |
MICHAELA RIVKOWICH |
Regulation Number | 870.1210
|
Classification Product Code |
|
Date Received | 09/08/2008 |
Decision Date | 12/30/2008 |
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
|
|
|