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Intimax Thrombectomy Catheter

by Applied Vascular Devices, Inc.

510(k) K910372

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK910372 Date26 Apr 1991ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1824-2024 FDA Class II initiated 17 Apr 2024

    The guide tip can become damaged and result in the tip detaching.

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  • Withdrawn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
DXE
Device Class
Class II
Regulation
21 CFR Part 870.5150
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Intimax Thrombectomy Catheter is a catheter used for embolectomy. It is a medical device designed to remove thrombi from blood vessels.

The device is supplied by Applied Vascular Devices, Inc. and has a product code of DXE. It is classified as a class 2 device with the regulation number 870.5150. The device has been cleared with a Traditional 510K clearance and has a decision description of Substantially Equivalent.

Other devices from Applied Vascular Devices, Inc.

See all devices from Applied Vascular Devices, Inc. →

Questions

AI-generated answers, 23 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 Intimax Thrombectomy Catheter used for?

    The Intimax Thrombectomy Catheter is used for embolectomy, which is a procedure to remove thrombi from blood vessels.

  • How is the Intimax Thrombectomy Catheter supplied?

    The device is supplied by Applied Vascular Devices, Inc.

  • What is the regulatory classification of the Intimax Thrombectomy Catheter?

    The device is classified as a class 2 device with the regulation number 870.5150.

  • What type of clearance does the Intimax Thrombectomy Catheter have?

    The device has been cleared with a Traditional 510K clearance and has a decision description of Substantially Equivalent.