Cleared Special

K230283 - Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)

K230283 is an FDA 510(k) clearance for Peel-Away Introducer (405104, manufactured by Abbott Medical. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 28-day FDA review.

K230283 · Abbott Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
28d
Days
Class 2
Risk

K230283 is an FDA 510(k) clearance for the Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120,.... Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Abbott Medical (Sylmar, US). The FDA issued a Cleared decision on March 1, 2023 after a review of 28 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.

FDA 510(k) Submission Details - K230283

510(k) Number K230283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2023
Decision Date March 01, 2023
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

DYB Device Classification - Class 2, Special Controls

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 705
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K230283.
CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
K231412 · Biosense Webster, Inc. · Jul 2023
Kodiak™ Dual Port Coaxial Introducer Kit
K230631 · Argon Medical Devices · May 2023
RAIN Sheath™ Tibial Pedal Introducer
K230704 · Cordis US Corp · Apr 2023
Introducer Sheath Kits
K222184 · Beijing Demax Medical Technology Co.,Ltd · Feb 2023
14F iSLEEVE™ Introducer Set
K230051 · Boston Scientific Corporation · Feb 2023
Low Profile Companion Sheath
K223872 · Merit Medical Systems, Inc. · Jan 2023
K230283 · Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)
Download PDF FDA Summary Abbott Medical