K990953 is an FDA 510(k) clearance for the RENAL LINK. This device is classified as a System, Dialysate Delivery, Semi-automatic, Peritoneal (Class II - Special Controls, product code KPF).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on June 18, 1999, 88 days after receiving the submission on March 22, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K990953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1999 |
| Decision Date | June 18, 1999 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPF — System, Dialysate Delivery, Semi-automatic, Peritoneal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |