Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K053171 |
Device Name |
MERIT IMPRESS DIAGNOSTIC CATHETER |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. |
SOUTH JORDAN,
UT
84095
|
|
Applicant Contact |
STEPHANIE ERSKINE |
Correspondent |
KEMA QUALITY B.V. |
4377 COUNTY LINE ROAD |
CHALFONT,
PA
18914
|
|
Correspondent Contact |
J.A. VAN VUGT |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 11/14/2005 |
Decision Date | 01/19/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|