CO-AXIAL INTRODUCER NEEDLE

• K Number: K022634
• Device Name: CO-AXIAL INTRODUCER NEEDLE
• Manufacturer: PROMEX, INC.
• Date Cleared: 2002-11-06 ( 90 days)
• Product Code: DYB
• Regulation Number: 870.1340
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

This device is intended to be used for percutaneous transjugular li access during diagnostic and interventional procedures.

Device Description

Co-Axial Introducer Needle; Co-Axial Introducer Set/Transjugular Liver Access Set

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called a "Co-Axial Introducer Needle" or "Co-Axial Introducer Set/Transjugular Liver Access Set" manufactured by Promex, Inc.

The letter grants clearance for the device to be marketed based on its substantial equivalence to a legally marketed predicate device. This type of regulatory document does not contain information about specific acceptance criteria or detailed study results proving a device meets those criteria, particularly not in the context of an AI/ML device where performance metrics like sensitivity, specificity, or AUC would be relevant.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval, not on detailed performance study outcomes typically associated with AI/ML device evaluations.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).