Cleared Special

Introducer Sheath Kits

K242248 · Beijing Demax Medical Technology Co.,Ltd · Cardiovascular
Aug 2024
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K242248 is an FDA 510(k) clearance for the Introducer Sheath Kits, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Beijing Demax Medical Technology Co.,Ltd (Beijing, CN). The FDA issued a Cleared decision on August 22, 2024, 22 days after receiving the submission on July 31, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K242248 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2024
Decision Date August 22, 2024
Days to Decision 22 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

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