The following data is part of a premarket notification filed by Aga Medical Corporation with the FDA for Amplatzer Torqvue Fx.
| Device ID | K121611 |
| 510k Number | K121611 |
| Device Name: | AMPLATZER TORQVUE FX |
| Classification | Catheter, Percutaneous |
| Applicant | AGA MEDICAL CORPORATION 5050 NATHAN LANE Plymouth, MN 55433 |
| Contact | Sherry Kollmann |
| Correspondent | Sherry Kollmann AGA MEDICAL CORPORATION 5050 NATHAN LANE Plymouth, MN 55433 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-01 |
| Decision Date | 2012-08-23 |
| Summary: | summary |