ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120

• K Number: K061951
• Device Name: ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120
• Manufacturer: POSSIS MEDICAL, INC.
• Date Cleared: 2006-11-22 ( 135 days)
• Product Code: QEZ , DXE , KRA
• Regulation Number: 870.5150
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K993564

Intended Use

The AngioJet Xpeedior 120 Rheolytic Thrombectomy Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infra-inquinal peripheral arteries 3.0 mm in diameter and upper extremity and infrainguinal lower extremity peripheral veins > 3.0 mm in diameter.

Device Description

When used with the AngioJet System, the Xpeedior Rheolytic Thrombectomy Catheter uses high velocity saline jets to percutaneously break-up and remove thrombus. These suline jests are contained within the Catheter and provide the suction that produces this effect.

AI/ML Overview

This document is a 510(k) summary for a medical device called the AngioJet Xpeedior 120 Rheolytic Thrombectomy Catheter. It outlines the device's intended use and claims substantial equivalence to previously cleared devices. It does NOT contain information about acceptance criteria or supporting studies that prove the device meets acceptance criteria.

The provided text from the 510(k) submission (K061951) for the AngioJet XPEEDIOR 120 Rheolytic Thrombectomy Catheter does not include any acceptance criteria, detailed study designs, or performance data tables.

The document primarily focuses on:

• The FDA's administrative change to the product code.
• The original substantial equivalence determination letter.
• The device's indications for use.
• A brief device description.
• A statement that "Applicable preclinical and clinical experience support the expanded indications for use," but without providing any specifics of these studies.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and studies from the provided text. To answer your questions, one would need access to the full 510(k) submission, which would typically contain detailed testing protocols, results, and acceptance criteria.

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).