Cleared Special

iSLEEVE Introducer Set

K190184 · Boston Scientific · Cardiovascular
Mar 2019
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K190184 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 Hennepin, US). The FDA issued a Cleared decision on March 7, 2019, 34 days after receiving the submission on February 1, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K190184 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2019
Decision Date March 07, 2019
Days to Decision 34 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