6F ENGAGE/ENGAGE TR INTRODUCER

• K Number: K101883
• Device Name: 6F ENGAGE/ENGAGE TR INTRODUCER
• Manufacturer: ST. JUDE MEDICAL
• Date Cleared: 2010-09-07 ( 63 days)
• Product Code: DYB
• Regulation Number: 870.1340
• Type: Special
• Panel: CV
• Reference & Predicate Devices: K101882
• Predicate For: N/A

Intended Use

The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into The introduction of the catheero, emoral, radial, and brachial access) where minimizing blood loss is essential.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Engage™/Engage™ TR Introducer). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

This document does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment for an AI/ML medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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).