Device Classification Name |
Syringe, Balloon Inflation
|
510(k) Number |
K122321 |
Device Name |
BASIXCONPAK ANALOG INFLATION SYRINGE |
Applicant |
MERIT MEDICAL IRELAND, LTD. |
1600 WEST MERIT PARKWAY |
SOUTH JORDAN,
UT
84095
|
|
Applicant Contact |
STEPHANIE ERSKINE |
Correspondent |
MERIT MEDICAL IRELAND, LTD. |
1600 WEST MERIT PARKWAY |
SOUTH JORDAN,
UT
84095
|
|
Correspondent Contact |
STEPHANIE ERSKINE |
Regulation Number | 870.1650
|
Classification Product Code |
|
Date Received | 08/01/2012 |
Decision Date | 12/19/2012 |
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
|
|
|