Cleared Traditional

10F Sheath and Dilator Set

K233432 · Argon Medical Devices, Inc. · Cardiovascular
Dec 2023
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K233432 is an FDA 510(k) clearance for the 10F Sheath and Dilator Set, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on December 8, 2023, 57 days after receiving the submission on October 12, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K233432 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 2023
Decision Date December 08, 2023
Days to Decision 57 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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