VYGON MICRO-ACCESS SAFETY INTRODUCER KIT

• K Number: K051248
• Device Name: VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
• Manufacturer: VYGON CORP.
• Date Cleared: 2005-10-27 ( 164 days)
• Product Code: DYB
• Regulation Number: 870.1340
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

This introducer kit is intended for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads into the vasculature.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text is a scanned document from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

The document is a clearance letter stating that the Vygon Micro-Access Safety Introducer Kit has been found substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and provides contact information.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving 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).