K211035 is an FDA 510(k) clearance for the U9000 Plus Ultrafilter. This device is classified as a Subsystem, Water Purification (Class II - Special Controls, product code FIP).
Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on October 19, 2021, 195 days after receiving the submission on April 7, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K211035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2021 |
| Decision Date | October 19, 2021 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIP — Subsystem, Water Purification |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5665 |