K073264 is an FDA 510(k) clearance for the D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005. This device is classified as a Hemostatic Wound Dressing With Thrombin Or Other Biologics.
Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 7, 2007, 17 days after receiving the submission on November 20, 2007.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K073264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2007 |
| Decision Date | December 07, 2007 |
| Days to Decision | 17 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QSX — Hemostatic Wound Dressing With Thrombin Or Other Biologics |
| Device Class | — |
| Definition | To Temporarily Control Bleeding And Cover External Wounds. |