Cleared Traditional

GORE DRYSEAL SHEATH (K093791) - FDA 510(k) Clearance

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

K093791 · W.L. Gore & Associates, Inc. · Cardiovascular device
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Mar 2010
Decision
102d
Days
Class 2
Risk

K093791 is an FDA 510(k) clearance for the GORE DRYSEAL SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on March 22, 2010 after a review of 102 days - within the typical 510(k) review window.

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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K093791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2009
Decision Date March 22, 2010
Days to Decision 102 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
23d faster than avg
Panel avg: 125d · This submission: 102d
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 223
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K093791.
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
K123990 · Medtronic Vascular · Apr 2013
EQUAFLOW MULTIVALVE INFUSION CATHETER
K123235 · Cook Incorporated · Feb 2013
PRELUDE 7F SHORT SHEATH INTRODUCER
K122190 · Merit Medical Systems, Inc. · Aug 2012
PRELUDE SHORT SHEATH INTRODUCER
K082063 · Merit Medical Systems, Inc. · Oct 2008
CONVOY ADVANCED DELIVERY SHEATH
K072719 · Boston Scientific Corp · Mar 2008
AIRGUARD VALVED INTRODUCER
K042036 · C.R. Bard, Inc. · Aug 2004