The following data is part of a premarket notification filed by Vascular Solutions, Inc. with the FDA for Thrombix 3x3 Hemostatic Pad.
| Device ID | K053054 |
| 510k Number | K053054 |
| Device Name: | THROMBIX 3X3 HEMOSTATIC PAD |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-10-31 |
| Decision Date | 2005-11-23 |
| Summary: | summary |