HQS Introducer (Model 2064-HQS)

• K Number: K153494
• Device Name: HQS Introducer (Model 2064-HQS)
• Manufacturer: ALSEAL
• Date Cleared: 2016-08-25 ( 265 days)
• Product Code: DYB
• Regulation Number: 870.1340
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

HQS Introducer (Model 2064-HQS) is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device called the "HQS Introducer (Model 2064-HQS)". It does not describe any acceptance criteria or studies related to AI/algorithm performance. Therefore, I cannot extract the requested information from the provided text.

The document is a regulatory communication stating that the device is substantially equivalent to legally marketed predicate devices, allowing its commercialization. It discusses administrative details, regulatory compliance, and indications for use of the catheter introducer, but it does not contain information about an AI or algorithm-based device, its performance, or studies demonstrating its effectiveness.

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).