AMECO SHEATH INTRODUCER

• K Number: K131144
• Device Name: AMECO SHEATH INTRODUCER
• Manufacturer: AMECO MEDICAL INDUSTRIES
• Date Cleared: 2013-08-15 ( 114 days)
• Product Code: DYB
• Regulation Number: 870.1340
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The Percutaneous sheath introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth for a medical device. The document is an FDA 510(k) clearance letter for an "Ameco Sheath Introducer" and primarily addresses its regulatory status and substantial equivalence to predicate devices. It outlines general controls, regulations, and contact information, but it does not include any performance study data or detailed information that would allow me to answer your questions.

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).