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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

Manufacturer

Zhuhai DR Medical Instruments Co., Ltd.

Date Cleared

2026-03-05

(267 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Age Range

All

Reference & Predicate Devices

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The Extension tube is intended as a connecting line for injection of a contrast and saline during coronary angiography procedures.

Device Description

The Extension tube is made up of connectors, male and/or female luer, caps and tubing, with the maximum injection pressure of 1200psi, as a connecting line for direct injection of contrast media or saline. It is single use and supplied sterile by Ethylene Oxide.

AI/ML Overview

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