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Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041, 106553, 105039

by Possis Medical, Inc.

510(k) K071342

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK071342 Date31 Jul 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QEZ
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.5150
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The AngioJet Ultra Xpeedior Thrombectomy Set is an aspiration thrombectomy catheter designed for mechanical removal of thrombus from peripheral arteries and veins. It functions by breaking apart and removing blood clots using a catheter and pump unit system. The device is intended for use with the AngioJet Ultra Console and is classified as a cardiovascular medical device.

This sterile, single-use, disposable device is supplied in various models including 105040, 105042, 106552, 105043, 105041, 106553, and 105039. It received FDA 510(k) clearance on July 31, 2007, with the product code QEZ and is regulated under 870.5150. The device is designed to treat thrombosed vessels ranging from small diameters to large clot burdens in peripheral vascular systems.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the AngioJet Ultra Xpeedior Thrombectomy Set used for?

    The AngioJet Ultra Xpeedior Thrombectomy Set is an aspiration thrombectomy catheter designed for mechanical removal of thrombus from peripheral arteries and veins. It breaks apart and removes blood clots using a catheter and pump unit system.

  • How is the AngioJet Ultra Xpeedior Thrombectomy Set supplied?

    This sterile, single-use, disposable device is supplied in various models including 105040, 105042, 106552, 105043, 105041, 106553, and 105039. It is designed to be used with the AngioJet Ultra Console.

  • What vessels can the AngioJet Ultra Xpeedior Thrombectomy Set treat?

    The device is designed to treat thrombosed vessels ranging from small diameters to large clot burdens in peripheral vascular systems, making it suitable for various vascular conditions.

  • What is the regulatory status of the AngioJet Ultra Xpeedior Thrombectomy Set?

    The device received FDA 510(k) clearance on July 31, 2007, with the product code QEZ and is regulated under 870.5150. It is classified as a cardiovascular medical device and is substantially equivalent to predicate devices.