K860155 is an FDA 510(k) clearance for the PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8. This device is classified as a Catheter, Peritoneal Dialysis, Single Use (Class II - Special Controls, product code FKO).
Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on February 14, 1986, 29 days after receiving the submission on January 16, 1986.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K860155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | January 16, 1986 |
| Decision Date | February 14, 1986 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FKO — Catheter, Peritoneal Dialysis, Single Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |