The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Twin-pass Torque.
| Device ID | K162467 |
| 510k Number | K162467 |
| Device Name: | Twin-Pass Torque |
| Classification | Catheter, Percutaneous |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Lisa Gallatin |
| Correspondent | Lisa Gallatin VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-02 |
| Decision Date | 2017-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M20652010 | K162467 | 000 |
| 30841156100364 | K162467 | 000 |