The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Gel-bead (600-800 Micron) - 1 Ml Sphere Volume, Gel-bead (600-800 Micron) - 2 Ml Sphere Volume.
| Device ID | K173891 |
| 510k Number | K173891 |
| Device Name: | Gel-Bead (600-800 Micron) - 1 Ml Sphere Volume, Gel-Bead (600-800 Micron) - 2 Ml Sphere Volume |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | Vascular Solutions, Inc. 6464 Sycamore Court N Minneapolis, MN 55369 |
| Contact | Lisa Gallatin |
| Correspondent | Lisa Gallatin Vascular Solutions, Inc. 6464 Sycamore Court N Minneapolis, MN 55369 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-21 |
| Decision Date | 2018-01-19 |
| Summary: | summary |