K240818 is an FDA 510(k) clearance for the R2P Radifocus Glidewire Advantage. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Terumo Corporation (Tokyo, JP). The FDA issued a Cleared decision on November 26, 2024, 246 days after receiving the submission on March 25, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K240818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2024 |
| Decision Date | November 26, 2024 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQX - Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |