K820909 is an FDA 510(k) clearance for the GORE-TEX PERITONEAL CATHETERR. This device is classified as a Catheter, Peritoneal, Long-term Indwelling (Class II - Special Controls, product code FJS).
Submitted by W.L. Gore & Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1982, 50 days after receiving the submission on April 1, 1982.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K820909 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 1982 |
| Decision Date | May 21, 1982 |
| Days to Decision | 50 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 |