Cleared Traditional

Halo One Thin-Walled Guiding Sheath

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

About This 510(k) Submission

K192313 is an FDA 510(k) clearance for the Halo One Thin-Walled Guiding Sheath, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by C.R. Bard, Inc. (Enniscorthy, IE). The FDA issued a Cleared decision on December 19, 2019, 115 days after receiving the submission on August 26, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K192313 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340

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