Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K120120 |
Device Name |
AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH |
Applicant |
AGA MEDICAL CORPORATION |
5050 NATHAN LANE |
PLYMOUTH,
MN
55433
|
|
Applicant Contact |
RASHMI BHUSHAN |
Correspondent |
AGA MEDICAL CORPORATION |
5050 NATHAN LANE |
PLYMOUTH,
MN
55433
|
|
Correspondent Contact |
RASHMI BHUSHAN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 01/17/2012 |
Decision Date | 03/15/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|