Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K080757 |
Device Name |
AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM |
Applicant |
AGA MEDICAL CORP. |
5050 NATHAN LANE NORTH |
PLYMOUTH,
MN
55442
|
|
Applicant Contact |
RASHMI BHUSHAN |
Correspondent |
AGA MEDICAL CORP. |
5050 NATHAN LANE NORTH |
PLYMOUTH,
MN
55442
|
|
Correspondent Contact |
RASHMI BHUSHAN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 03/18/2008 |
Decision Date | 04/18/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|