K231849 is an FDA 510(k) clearance for the MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A. This device is classified as a Set, Administration, For Peritoneal Dialysis, Disposable (Class II - Special Controls, product code KDJ).
Submitted by Baxter Healthcare (Round Lake, US). The FDA issued a Cleared decision on March 12, 2024, 263 days after receiving the submission on June 23, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K231849 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2023 |
| Decision Date | March 12, 2024 |
| Days to Decision | 263 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 |