The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Thrombigel Thrombin/gelatin Foam Hemostat.
| Device ID | K053644 |
| 510k Number | K053644 |
| Device Name: | THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT |
| Classification | Dressing, Wound, Drug |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | Linda Busklein |
| Correspondent | Linda Busklein VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-12-30 |
| Decision Date | 2006-02-09 |
| Summary: | summary |