K850214 is an FDA 510(k) clearance for the STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN. This device is classified as a Catheter, Peritoneal, Long-term Indwelling (Class II - Special Controls, product code FJS).
Submitted by Accurate Surgical Instruments Co. (Toronto Canado M5v 1y9, CA). The FDA issued a Cleared decision on July 26, 1985, 185 days after receiving the submission on January 22, 1985.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K850214 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 1985 |
| Decision Date | July 26, 1985 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FJS — Catheter, Peritoneal, Long-term Indwelling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |