Cleared Traditional

K192313 - Halo One Thin-Walled Guiding Sheath

K192313 is the FDA 510(k) clearance for Halo One Thin-Walled Guiding Sheath by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K192313 · C.R. Bard, Inc. · Cardiovascular device
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Dec 2019
Decision
115d
Days
Class 2
Risk

K192313 is an FDA 510(k) clearance for the Halo One Thin-Walled Guiding Sheath. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Enniscorthy, IE). The FDA issued a Cleared decision on December 19, 2019 after a review of 115 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K192313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2019
Decision Date December 19, 2019
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
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 390
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K192313.
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R2P Destination Slender Guiding Sheath
K193125 · Terumo Medical Corporation · Jan 2020
Glidesheath Slender Tibial Pedal Kit
K193160 · Terumo Medical Coporation · Dec 2019
Impella CP Introducer
K192769 · Abiomed, Inc. · Nov 2019
AcQRef Introducer Sheath
K192106 · Acutus Medical, Inc. · Sep 2019