K221528 is an FDA 510(k) clearance for the Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter. This device is classified as a Catheter, Septostomy (Class II - Special Controls, product code DXF).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on August 22, 2022, 88 days after receiving the submission on May 26, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5175.
| 510(k) Number | K221528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2022 |
| Decision Date | August 22, 2022 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXF — Catheter, Septostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5175 |