Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K083214 |
Device Name |
AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 |
Applicant |
AGA MEDICAL CORP. |
5050 NATHAN LANE NORTH |
PLYMOUTH,
MN
55442
|
|
Applicant Contact |
DIANE CARROLL |
Correspondent |
AGA MEDICAL CORP. |
5050 NATHAN LANE NORTH |
PLYMOUTH,
MN
55442
|
|
Correspondent Contact |
DIANE CARROLL |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 10/31/2008 |
Decision Date | 05/12/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|