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K Number
K222182
Device Name
Radial Artery Compression Tourniquets
Manufacturer
Beijing Demax Medical Technology Co., Ltd.
Date Cleared
2023-01-04

(166 days)

Product Code
DXC
Regulation Number
870.4450
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Radial Artery Compression Tourniquet is designed for temporary hemostasis of radial artery post percutaneous puncture.

Device Description

Radial Artery Compression Tourniquets

AI/ML Overview

The provided document is a 510(k) clearance letter for the "Radial Artery Compression Tourniquets" and does not contain the specific information about acceptance criteria, device performance, study details, or AI-related data as requested. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but does not include the detailed technical study information you're looking for.

Therefore, I cannot provide the requested information based on the input text.

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).