K931120 is an FDA 510(k) clearance for the COAXIAL ACUTE CATHETER, a Catheter, Subclavian (Class II — Special Controls, product code LFJ), submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on January 14, 1994, 316 days after receiving the submission on March 4, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K931120 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 04, 1993 |
| Decision Date | January 14, 1994 |
| Days to Decision | 316 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | LFJ — Catheter, Subclavian |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5540 |