The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Thrombix Patch Thrombin Hemostasis Patch.
| Device ID | K072117 |
| 510k Number | K072117 |
| Device Name: | THROMBIX PATCH THROMBIN HEMOSTASIS PATCH |
| Classification | Dressing, Wound, Drug |
| Applicant | VASCULAR SOLUTIONS, INC. 6464 SYCAMORE COURT Minneapolis, MN 55369 |
| Contact | James Chapman |
| Correspondent | James Chapman 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 | 2007-08-01 |
| Decision Date | 2007-10-05 |
| Summary: | summary |