K102212 is an FDA 510(k) clearance for the D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER. This device is classified as a Hemostatic Wound Dressing With Thrombin Or Other Biologics.
Submitted by Vascular Solutions, Inc. (Maple Grove, US). The FDA issued a Cleared decision on April 8, 2011, 245 days after receiving the submission on August 6, 2010.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K102212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2010 |
| Decision Date | April 08, 2011 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| 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. |