K223874 is an FDA 510(k) clearance for the BAROguard, a System, Perfusion, Kidney (Class II — Special Controls, product code KDN), submitted by Paragonix Technologies (Braintree, US). The FDA issued a Cleared decision on August 15, 2023, 235 days after receiving the submission on December 23, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K223874 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 23, 2022 |
| Decision Date | August 15, 2023 |
| Days to Decision | 235 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDN — System, Perfusion, Kidney |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5880 |