K925243 is an FDA 510(k) clearance for the DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER, a Catheter, Irrigation (Class I — General Controls, product code GBX), submitted by Deknatel, Inc. (San Jose-Heredia, CR). The FDA issued a Cleared decision on July 27, 1994, 649 days after receiving the submission on October 16, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K925243 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 16, 1992 |
| Decision Date | July 27, 1994 |
| Days to Decision | 649 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GBX — Catheter, Irrigation |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4200 |