Cleared Traditional

K142357 - DuraSheath Introducer Sheath System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K142357 · Contract Medical International, GmbH · Cardiovascular device
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Jun 2015
Decision
304d
Days
Class 2
Risk

K142357 is an FDA 510(k) clearance for the DuraSheath Introducer Sheath System. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Contract Medical International, GmbH (Dresden, DE). The FDA issued a Cleared decision on June 25, 2015 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Contract Medical International, GmbH devices

Submission Details

510(k) Number K142357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2014
Decision Date June 25, 2015
Days to Decision 304 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
179d slower than avg
Panel avg: 125d · This submission: 304d
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 700
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K142357.
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K260942 · CenterPoint Systems, LLC · Apr 2026