K031676 is an FDA 510(k) clearance for the HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q. This device is classified as a Set, Administration, For Peritoneal Dialysis, Disposable (Class II - Special Controls, product code KDJ).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on November 20, 2003, 174 days after receiving the submission on May 30, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K031676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2003 |
| Decision Date | November 20, 2003 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDJ — Set, Administration, For Peritoneal Dialysis, Disposable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |