K121383 is an FDA 510(k) clearance for the PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS). This device is classified as a Catheter, Peritoneal, Long-term Indwelling (Class II - Special Controls, product code FJS).
Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on September 5, 2012, 120 days after receiving the submission on May 8, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K121383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | May 08, 2012 |
| Decision Date | September 05, 2012 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJS — Catheter, Peritoneal, Long-term Indwelling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |