Occlusion Perfusion Catheter

• K Number: K153488
• Device Name: Occlusion Perfusion Catheter
• Manufacturer: Advanced Catheter Therapies, Inc.
• Date Cleared: 2016-02-25 ( 83 days)
• Product Code: QEY , DQY
• Regulation Number: 870.5150
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The Occlusion Perfusion Catheter™ is indicated for localized infusion of various diagnostic and therapeutic agents into the peripheral vasculature. The Occlusion Perfusion Catheter™ may be repositioned for multiple treatments with the same patient. It is not indicated for use in the neurovasculature.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a device called "Occlusion Perfusion Catheter™", along with its indications for use. It primarily discusses regulatory aspects and does not delve into detailed performance studies or statistical evidence.

Therefore, I cannot provide the requested information in the specified format.

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).