Cleared Traditional

Introducer Sheath Kits

K222184 · Beijing Demax Medical Technology Co.,Ltd · Cardiovascular
Feb 2023
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K222184 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 February 21, 2023, 214 days after receiving the submission on July 22, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K222184 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2022
Decision Date February 21, 2023
Days to Decision 214 days
Submission Type Traditional
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