Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K121611 |
Device Name |
AMPLATZER TORQVUE FX |
Applicant |
AGA MEDICAL CORPORATION |
5050 NATHAN LANE |
PLYMOUTH,
MN
55433
|
|
Applicant Contact |
SHERRY KOLLMANN |
Correspondent |
AGA MEDICAL CORPORATION |
5050 NATHAN LANE |
PLYMOUTH,
MN
55433
|
|
Correspondent Contact |
SHERRY KOLLMANN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 06/01/2012 |
Decision Date | 08/23/2012 |
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
|
|
|