K070938 is an FDA 510(k) clearance for the THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT. 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 August 6, 2007, 124 days after receiving the submission on April 4, 2007.
This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..
| 510(k) Number | K070938 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2007 |
| Decision Date | August 06, 2007 |
| Days to Decision | 124 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. |