K083190 is an FDA 510(k) clearance for the D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015. 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 November 12, 2008, 14 days after receiving the submission on October 29, 2008.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K083190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 2008 |
| Decision Date | November 12, 2008 |
| Days to Decision | 14 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. |