The following data is part of a premarket notification filed by Aga Medical Corporation (wholly Owned By St. Jude Medical Co with the FDA for Amplatzer Torqvue 45x45 Delivery Sheath.
| Device ID | K163000 |
| 510k Number | K163000 |
| Device Name: | AMPLATZER TorqVue 45x45 Delivery Sheath |
| Classification | Catheter, Percutaneous |
| Applicant | AGA Medical Corporation (Wholly Owned By St. Jude Medical Co 5050 Nathan Lane Plymouth, MN 55442 |
| Contact | Mary Johnson |
| Correspondent | Mary Johnson AGA Medical Corporation (Wholly Owned By St. Jude Medical Co 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 | 2016-10-28 |
| Decision Date | 2016-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067025906 | K163000 | 000 |
| 05415067025883 | K163000 | 000 |