Cleared Special

Halo One Thin-Walled Guiding Sheath

K212708 · C.R. Bard, Inc. · Cardiovascular
Sep 2021
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K212708 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 September 23, 2021, 28 days after receiving the submission on August 26, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K212708 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2021
Decision Date September 23, 2021
Days to Decision 28 days
Submission Type Special
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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