K203262 is an FDA 510(k) clearance for the Cannula for Organ Perfusion. This device is classified as a System, Perfusion, Kidney (Class II - Special Controls, product code KDN).
Submitted by Bridge TO Life, Ltd. (Columbia, US). The FDA issued a Cleared decision on July 1, 2021, 238 days after receiving the submission on November 5, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K203262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2020 |
| Decision Date | July 01, 2021 |
| Days to Decision | 238 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 |