Cleared Special

Low Profile Companion Sheath

K223872 · Merit Medical Systems, Inc. · Cardiovascular
Jan 2023
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K223872 is an FDA 510(k) clearance for the Low Profile Companion Sheath, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on January 19, 2023, 27 days after receiving the submission on December 23, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K223872 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2022
Decision Date January 19, 2023
Days to Decision 27 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