Cleared Special

K153246 - PTFE Super Sheath Introducer 2.1

K153246 is an FDA 510(k) clearance for PTFE Super Sheath Introducer 2.1, manufactured by Medcomp (Medical Components, Inc.). The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 95-day FDA review.

K153246 · Medcomp (Medical Components, Inc.) · Cardiovascular device
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Feb 2016
Decision
95d
Days
Class 2
Risk

K153246 is an FDA 510(k) clearance for the PTFE Super Sheath Introducer 2.1. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Medcomp (Medical Components, Inc.) (Harleysville, US). The FDA issued a Cleared decision on February 12, 2016 after a review of 95 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medcomp (Medical Components, Inc.) devices

FDA 510(k) Submission Details - K153246

510(k) Number K153246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2015
Decision Date February 12, 2016
Days to Decision 95 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
30d faster than avg
Panel avg: 125d · This submission: 95d
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 646
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K153246.
transGlide Expandable Introducer
K152194 · Transaortic Medical, Inc. · Apr 2016
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
K153430 · Cook Incorporated · Mar 2016
Endophys Pressure Sensing Sheath Kit
K160272 · Endophys, Inc. · Mar 2016
Fortress Introducer Sheath SYstem
K153197 · Contract Medical International, GmbH · Jan 2016
SoloPath Re-Collapsible Access System
K152498 · Onset Medical Corporation · Jan 2016
Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle
K151936 · Synaptic Medical Limited · Dec 2015