The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Amplatzer Torq Vue Lp Delivery System.
| Device ID | K131063 |
| 510k Number | K131063 |
| Device Name: | AMPLATZER TORQ VUE LP DELIVERY SYSTEM |
| Classification | Catheter, Percutaneous |
| Applicant | ST. JUDE MEDICAL 5050 NATHAN LANE NORTH Plymouth, MN 55442 |
| Contact | Heather Taylor |
| Correspondent | Heather Taylor ST. JUDE MEDICAL 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 | 2013-04-16 |
| Decision Date | 2013-08-15 |
| Summary: | summary |