The following data is part of a premarket notification filed by Aga Medical Corporation with the FDA for Amplatzer Torqvue 45x45 Delivery Sheath Amplatzer Torqvue La1 Delivery Sheath Amplatzer Torqvue La2 Selivery Sheath.
| Device ID | K120120 |
| 510k Number | K120120 |
| Device Name: | AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH |
| Classification | Catheter, Percutaneous |
| Applicant | AGA MEDICAL CORPORATION 5050 NATHAN LANE Plymouth, MN 55433 |
| Contact | Rashmi Bhushan |
| Correspondent | Rashmi Bhushan AGA MEDICAL CORPORATION 5050 NATHAN LANE Plymouth, MN 55433 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-17 |
| Decision Date | 2012-03-15 |
| Summary: | summary |