Cleared Traditional

K142357 - DuraSheath Introducer Sheath System

K142357 is an FDA 510(k) clearance for DuraSheath Introducer Sheath System, manufactured by Contract Medical International, GmbH. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 304-day FDA review.

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

FDA 510(k) Submission Details - K142357

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.

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 433
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K142357.
Confida Adaptive Sheath
K152054 · Medtronic, Inc. · Aug 2015
Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification
K142829 · Cook Incorporated · Jul 2015
Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set
K142819 · Cook Incorporated · Jul 2015
PreludeEASE Hydrophilic Sheath Introducer
K150257 · Merit Medical Systems, Inc. · Jun 2015
Chariot Guiding Sheath
K150186 · Boston Scientific Corp · Jun 2015
PINPOINT GT SAFETY INTRODUCER NEEDLE
K142445 · C.R. Bard, Inc. · Apr 2015