VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE

• K Number: K961716
• Device Name: VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE
• Manufacturer: IDEAS FOR MEDICINE, INC.
• Date Cleared: 1996-09-19 ( 140 days)
• Product Code: DXE
• Regulation Number: 870.5150
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The catheters are intended for use in the removal of arterial emboli and thrombi during embolectomy and thrombectomy.

Device Description

The Vaso-Safe Arterial Embolectomy Catheter is a single lumen nylon tube with a natural latex balloon attached to a distal end and a stopcock affixed to the proximal end. It will be packaged with a syringe. The catheter will be available in 5 french sizes and 3 lengths.

AI/ML Overview

This document describes a medical device, the "Vaso-Safe Arterial Embolectomy Catheter," and its classification, description, and intended use. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The provided text is a summary of the device for regulatory purposes, not a clinical study report.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).