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Aspire RX-LP6 Aspiration Catheter

by Control Medical Technology

510(k) K131998

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 NumberK131998 Date26 Nov 2013ClearedStatusActive

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  • Withdrawn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
FDA applicant
Control Medical Technology, LLC
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 Aspire Rx-LP6 Aspiration Catheter is an embolectomy catheter designed for the removal of fresh, soft emboli and thrombi from vessels within the coronary and peripheral vasculature. The device system consists of a 6F rapid exchange aspiration catheter and a 30ml piston syringe.

This device has received FDA 510(k) clearance under the regulation number 870.5150. It is classified as a Class 2 cardiovascular device.

Other devices from Control Medical Technology

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 primary purpose of the Aspire Rx-LP6 Aspiration Catheter?

    This device is designed for the removal of fresh, soft emboli and thrombi from vessels located within the coronary and peripheral vasculature.

  • What components are included in the Aspire Rx-LP6 system?

    The system is supplied as a complete kit consisting of a 6F rapid exchange aspiration catheter and a 30ml piston syringe to facilitate the aspiration process.

  • What is the regulatory status of this device?

    The Aspire Rx-LP6 Aspiration Catheter has received FDA 510(k) clearance under regulation number 870.5150 and is classified as a Class 2 cardiovascular device.