The following data is part of a premarket notification filed by Aga Medical Corp. with the FDA for Amplatzer Torqvue Exchange System.
| Device ID | K080994 |
| 510k Number | K080994 |
| Device Name: | AMPLATZER TORQVUE EXCHANGE SYSTEM |
| Classification | Catheter, Percutaneous |
| Applicant | AGA MEDICAL CORP. 5050 NATHAN LANE NORTH Plymouth, MN 55442 |
| Contact | Michelle Nivala |
| Correspondent | Michelle Nivala AGA MEDICAL CORP. 5050 NATHAN LANE NORTH Plymouth, MN 55442 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-07 |
| Decision Date | 2008-05-16 |
| Summary: | summary |