The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Gel-block 10x Embolization Pledgets.
| Device ID | K143038 |
| 510k Number | K143038 |
| Device Name: | Gel-Block 10X Embolization Pledgets |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT NORTH Minneapolis, MN 55369 |
| Contact | Adam Ettl |
| Correspondent | Adam Ettl VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT NORTH 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 | 2014-10-22 |
| Decision Date | 2014-11-20 |
| Summary: | summary |