Cleared Traditional

DuraSheath Introducer Sheath System (K181463) - FDA 510(k) Clearance

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

K181463 · Contract Medical International, GmbH · Cardiovascular device
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Dec 2018
Decision
192d
Days
Class 2
Risk

K181463 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 December 13, 2018 after a review of 192 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 Contract Medical International, GmbH devices

Submission Details

510(k) Number K181463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2018
Decision Date December 13, 2018
Days to Decision 192 days
Submission Type Traditional
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
67d slower than avg
Panel avg: 125d · This submission: 192d
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 272
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K181463.
transGlideXT Expandable Introducer
K181817 · Transaortic Medical, Inc. · Mar 2019
Endophys Pressure Sensing Sheath
K190098 · Endophys Holdings, LLC · Mar 2019
iSLEEVE Introducer Set
K190184 · Boston Scientific · Mar 2019
TSI Transseptal Introducer
K181031 · Pressure Products Medical Device Manufacturing, LLC · Oct 2018
Endophys Pressure Sensing Sheath Kit
K180620 · Endophys Holdings, LLC · Oct 2018
TSP Crosser Transseptal Access System
K181088 · Transseptal Solutions , Ltd. · Sep 2018