K915490 is an FDA 510(k) clearance for the MEDCOMP PERITONEAL DIALYSIS CATHETERS. 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 February 2, 1994, 789 days after receiving the submission on December 6, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K915490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | December 06, 1991 |
| Decision Date | February 02, 1994 |
| Days to Decision | 789 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 |