K250468 is an FDA 510(k) clearance for the iSLEEVE Introducer Set. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on March 20, 2025, 30 days after receiving the submission on February 18, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K250468 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2025 |
| Decision Date | March 20, 2025 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |