Cleared Special

K233503 - 14F iSLEEVE Introducer Set

K233503 is the FDA 510(k) clearance for 14F iSLEEVE Introducer Set by Boston Scientific Corporation. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 30-day FDA review.

K233503 · Boston Scientific Corporation · Cardiovascular device
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Nov 2023
Decision
30d
Days
Class 2
Risk

K233503 is an FDA 510(k) clearance for the 14F iSLEEVE Introducer Set. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on November 30, 2023 after a review of 30 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 Corporation devices

Submission Details

510(k) Number K233503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2023
Decision Date November 30, 2023
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 391
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K233503.
FlexCath Cross Transseptal Solution
K233691 · Acutus Medical, Inc. · Dec 2023
Intri24 Introducer Sheath (52-101)
K233646 · Inari Medical, Inc. · Dec 2023
10F Sheath and Dilator Set
K233432 · Argon Medical Devices, Inc. · Dec 2023
Talon Transseptal Sheath
K231108 · Inari Medical, Inc. · Sep 2023
Thinline Sheath Introducer
K232260 · Inneuroco, Inc. · Sep 2023
Pounce™ Sheath
K231828 · Surmodics,Inc. · Sep 2023