Cleared Special

K190184 - iSLEEVE Introducer Set

K190184 is the FDA 510(k) clearance for iSLEEVE Introducer Set by Boston Scientific. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 34-day FDA review.

K190184 · Boston Scientific · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
34d
Days
Class 2
Risk

K190184 is an FDA 510(k) clearance for the iSLEEVE Introducer Set. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on March 7, 2019 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific devices

Submission Details

510(k) Number K190184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 125d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 390
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K190184.
VersaCross Steerable Sheath, VersaCross Transseptal Dilator
K190688 · Baylis Medical Company, Inc. · Apr 2019
transGlideXT Expandable Introducer
K181817 · Transaortic Medical, Inc. · Mar 2019
Endophys Pressure Sensing Sheath
K190098 · Endophys Holdings, LLC · Mar 2019
DuraSheath Introducer Sheath System
K181463 · Contract Medical International, GmbH · Dec 2018
TSI Transseptal Introducer
K181031 · Pressure Products Medical Device Manufacturing, LLC · Oct 2018
Endophys Pressure Sensing Sheath Kit
K180620 · Endophys Holdings, LLC · Oct 2018