The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Vsi Torque Device.
| Device ID | K100093 |
| 510k Number | K100093 |
| Device Name: | VSI TORQUE DEVICE |
| Classification | Wire, Guide, Catheter |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Jennifer Ruether |
| Correspondent | Jennifer Ruether VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-13 |
| Decision Date | 2010-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M20681810 | K100093 | 000 |