Cleared Traditional

Radial Compression Device

K232577 · Ningbo Dizegens Medical Science Co.,Ltd · Cardiovascular
Jan 2024
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K232577 is an FDA 510(k) clearance for the Radial Compression Device, a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Ningbo Dizegens Medical Science Co.,Ltd (Ningo, US). The FDA issued a Cleared decision on January 18, 2024, 146 days after receiving the submission on August 25, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K232577 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2023
Decision Date January 18, 2024
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXC — Clamp, Vascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4450

Similar Devices — DXC Clamp, Vascular

All 200
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
K243627 · Arc Trauma, LLC · Dec 2025
Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
K253070 · Medline Industries, LP · Nov 2025
PICOCLAMP
K230281 · Kono Seisakusho Co., Ltd. · Oct 2023
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
K221661 · Compression Works, Inc. · Mar 2023
VIOLA
K230248 · Vascular Graft Solutions, Ltd. · Feb 2023
Radial Artery Compression Tourniquets
K222182 · Beijing Demax Medical Technology Co.,Ltd · Jan 2023