K925818 is an FDA 510(k) clearance for the AKCESS-CATH. This device is classified as 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 April 5, 1994, 504 days after receiving the submission on November 17, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K925818 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 1992 |
| Decision Date | April 05, 1994 |
| Days to Decision | 504 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 |