Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K093476 |
Device Name |
AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 |
Applicant |
AGA MEDICAL CORP. |
5050 NATHAN LANE NORTH |
PLYMOUTH,
MN
55442
|
|
Applicant Contact |
AMANDA JOHNSON |
Correspondent |
AGA MEDICAL CORP. |
5050 NATHAN LANE NORTH |
PLYMOUTH,
MN
55442
|
|
Correspondent Contact |
AMANDA JOHNSON |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 11/09/2009 |
Decision Date | 02/05/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|