ENGAGE/ENGAGE TR INTRODUCERS

• K Number: K111092
• Device Name: ENGAGE/ENGAGE TR INTRODUCERS
• Manufacturer: ST. JUDE MEDICAL
• Date Cleared: 2011-06-09 ( 51 days)
• Product Code: DYB
• Regulation Number: 870.1340
• Type: Special
• Panel: CV
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Engage™ Introducer is indicated for the introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a blood vessel (including but not limited to femoral, radial, and brachial access) where minimizing blood loss is essential.

The Engage TR™ Introducer is indicated for the introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a radial vessel where minimizing blood loss is essential.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) summary for the Engage™/Engage TR™ Introducer does not contain information about acceptance criteria or a study that proves the device meets those criteria.

This document is a marketing clearance letter, which states that the device is substantially equivalent to legally marketed predicate devices. It does not include performance data, clinical study details, or specific acceptance criteria for the device itself.

Therefore, I cannot extract the requested information from 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).