K093915 is an FDA 510(k) clearance for the DEKA TAC DEVICE. This device is classified as a Clamp, Tubing, Blood, Automatic (Class II - Special Controls, product code FIG).
Submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on August 23, 2011, 609 days after receiving the submission on December 22, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K093915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2009 |
| Decision Date | August 23, 2011 |
| Days to Decision | 609 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIG - Clamp, Tubing, Blood, Automatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |