Device Classification Name |
Syringe, Balloon Inflation
|
510(k) Number |
K040138 |
Device Name |
VICEROY INFLATION DEVICE |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. |
SOUTH JORDAN,
UT
84095
|
|
Applicant Contact |
JOHN NICHOLSON |
Correspondent |
KEMA QUALITY B.V. |
P.O. BOX 5185 |
6802 ED ARNHEM |
ARNHEM,
NL
|
|
Correspondent Contact |
J.A. VAN VUGT |
Regulation Number | 870.1650
|
Classification Product Code |
|
Date Received | 01/22/2004 |
Decision Date | 02/13/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|