Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K163000 |
Device Name |
AMPLATZER TorqVue 45x45 Delivery Sheath |
Applicant |
AGA Medical Corporation (Wholly Owned by St. Jude Medical Co |
5050 Nathan Lane |
Plymouth,
MN
55442
|
|
Applicant Contact |
Mary Johnson |
Correspondent |
AGA Medical Corporation (Wholly Owned by St. Jude Medical Co |
5050 Nathan Lane |
Plymouth,
MN
55442
|
|
Correspondent Contact |
Mary Johnson |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 10/28/2016 |
Decision Date | 12/23/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|