The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Expro Elite Snare, Sympro Elite Snare.
| Device ID | K163307 |
| 510k Number | K163307 |
| Device Name: | Expro Elite Snare, Sympro Elite Snare |
| Classification | Device, Percutaneous Retrieval |
| Applicant | Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Jake Schultz |
| Correspondent | Jake Schultz Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Product Code | MMX |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-23 |
| Decision Date | 2017-03-08 |
| Summary: | summary |