K974570 is an FDA 510(k) clearance for the PERITONEAL DIALYSIS CATHETER CONNECTOR, a Catheter, Peritoneal Dialysis, Single Use (Class II — Special Controls, product code FKO), submitted by Medigroup, Inc. (Aurora, US). The FDA issued a Cleared decision on February 27, 1998, 81 days after receiving the submission on December 8, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K974570 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 08, 1997 |
| Decision Date | February 27, 1998 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FKO — Catheter, Peritoneal Dialysis, Single Use |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5630 |