K213602 is an FDA 510(k) clearance for the Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit. This device is classified as a Catheter, Peritoneal, Long-term Indwelling (Class II - Special Controls, product code FJS).
Submitted by Covidien, LLC (Mansfield, US). The FDA issued a Cleared decision on January 14, 2022, 60 days after receiving the submission on November 15, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K213602 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2021 |
| Decision Date | January 14, 2022 |
| Days to Decision | 60 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 |