MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter

• K Number: K163233
• Device Name: MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter
• Manufacturer: MIVI NEUROSCIENCE, INC
• Date Cleared: 2017-04-06 ( 140 days)
• Product Code: DQY
• Regulation Number: 870.1250
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The MIVI Mi-EXT Catheter is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

Device Description

Not Found

AI/ML Overview

There is no information in the provided text about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) clearance letter for the MIVI Mi-EXT Catheter, indicating it has been found substantially equivalent to a predicate device. It specifies the intended use of the catheter but does not detail performance metrics, study design, or any of the other requested information.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).