The following data is part of a premarket notification filed by Aga Medical Corp. with the FDA for Amplatzer Torqvue 45degreex45degree Delivery Sheath, Models 9-tv45x45-09f-100, 9-tv45x45-10f-100.
| Device ID | K083214 |
| 510k Number | K083214 |
| Device Name: | AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 |
| Classification | Catheter, Percutaneous |
| Applicant | AGA MEDICAL CORP. 5050 NATHAN LANE NORTH Plymouth, MN 55442 |
| Contact | Diane Carroll |
| Correspondent | Diane Carroll AGA MEDICAL CORP. 5050 NATHAN LANE NORTH Plymouth, MN 55442 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-31 |
| Decision Date | 2009-05-12 |
| Summary: | summary |