K103245 is an FDA 510(k) clearance for the CELSTAT, a Hemostatic Wound Dressing Without Thrombin Or Other Biologics, submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on March 23, 2011, 141 days after receiving the submission on November 2, 2010. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K103245 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 02, 2010 |
| Decision Date | March 23, 2011 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QSY — Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
| Device Class | — |
| Definition | To Temporarily Control Bleeding And Cover External Wounds. |