K200720 is an FDA 510(k) clearance for the D-Stat Radial Topical Hemostat. This device is classified as a Hemostatic Wound Dressing With Thrombin Or Other Biologics.
Submitted by Vascular Solutions, LLC (Maple Grove, US). The FDA issued a Cleared decision on June 26, 2020, 99 days after receiving the submission on March 19, 2020.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K200720 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2020 |
| Decision Date | June 26, 2020 |
| Days to Decision | 99 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. |