The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Gel-block Embolization Pledgets.
| Device ID | K113266 |
| 510k Number | K113266 |
| Device Name: | GEL-BLOCK EMBOLIZATION PLEDGETS |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Contact | Jennifer Ruether |
| Correspondent | Jennifer Ruether VASCULAR SOLUTIONS, INC. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-04 |
| Decision Date | 2012-05-14 |
| Summary: | summary |