The following data is part of a premarket notification filed by Aga Medical Corp. with the FDA for Amplatzer Torq Vue 2 Delivery Sheath Model 9-tv2-05f120, Model 9-tv2-06f120, Modeltv-2-07f120.
| Device ID | K093476 |
| 510k Number | K093476 |
| Device Name: | AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 |
| Classification | Catheter, Percutaneous |
| Applicant | AGA MEDICAL CORP. 5050 NATHAN LANE NORTH Plymouth, MN 55442 |
| Contact | Amanda Johnson |
| Correspondent | Amanda Johnson 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 | 2009-11-09 |
| Decision Date | 2010-02-05 |
| Summary: | summary |