Cleared Special

iSLEEVE Introducer Set

K250468 · Boston Scientific · Cardiovascular
Mar 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K250468 is an FDA 510(k) clearance for the iSLEEVE Introducer Set, 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 review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K250468 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340