K233433 is an FDA 510(k) clearance for the Sphere-9Dx Diagnostic Catheter (AFR-00009). This device is classified as a Catheter, Intracardiac Mapping, High-density Array (Class II - Special Controls, product code MTD).
Submitted by Medtronic (Mounds View, US). The FDA issued a Cleared decision on August 7, 2024, 300 days after receiving the submission on October 12, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220.
| 510(k) Number | K233433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 2023 |
| Decision Date | August 07, 2024 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MTD — Catheter, Intracardiac Mapping, High-density Array |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |