Cleared Traditional

K181463 - DuraSheath Introducer Sheath System

K181463 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 192-day FDA review.

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

FDA 510(k) Submission Details - K181463

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.

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 432
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