The following data is part of a premarket notification filed by Aga Medical Corporation (wholly Owned By St.jude Medical Cor with the FDA for Torqvue Low Profile Delivery Catheter.
| Device ID | K162228 |
| 510k Number | K162228 |
| Device Name: | TorqVue Low Profile Delivery Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | AGA MEDICAL CORPORATION (WHOLLY OWNED BY ST.JUDE MEDICAL COR 5050 NATHAN LANE Plymouth, MN 55442 |
| Contact | Mary Johnson |
| Correspondent | Mary Johnson AGA MEDICAL CORPORATION (WHOLLY OWNED BY ST.JUDE MEDICAL COR 5050 NATHAN LANE 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 | 2016-08-08 |
| Decision Date | 2016-09-09 |
| Summary: | summary |