The following data is part of a premarket notification filed by Covidien, Llc with the FDA for Argyle Peritoneal Dialysis Cathetor And Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit.
| Device ID | K213602 |
| 510k Number | K213602 |
| Device Name: | Argyle Peritoneal Dialysis Cathetor And Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | Covidien, Llc 15 Hampshore Street Mansfield, MA 02048 |
| Contact | Carol S Ming |
| Correspondent | Carol S Ming Covidien, Llc 15 Hampshore Street Mansfield, MA 02048 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-15 |
| Decision Date | 2022-01-14 |