Cleared Traditional

K090394 - VALVED TEARWAY INTRODUCER

K090394 is the FDA 510(k) clearance for VALVED TEARWAY INTRODUCER by Medcomp. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K090394 · Medcomp · Cardiovascular device
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Sep 2009
Decision
196d
Days
Class 2
Risk

K090394 is an FDA 510(k) clearance for the VALVED TEARWAY INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Medcomp (Harleysville, US). The FDA issued a Cleared decision on September 1, 2009 after a review of 196 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medcomp devices

Submission Details

510(k) Number K090394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2009
Decision Date September 01, 2009
Days to Decision 196 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 125d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 326
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K090394.
GORE DRYSEAL SHEATH
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ENGAGE TR INTRODUCER
K093130 · St Jude Medical · Nov 2009
ENGAGE/ENGAGE TR
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K091329 · Terumo Medical Corp. · May 2009
ULTIMUM/ENGAGE/ENGAGE TR
K091137 · St Jude Medical · Apr 2009
AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
K083402 · St Jude Medical · Dec 2008