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Transluminal Endarterectomy Device

by Baxter Healthcare Corp

510(k) K904944

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 NumberK904944 Date17 Dec 1990ClearedStatusActive

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  • Withdrawn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
DWX
Device class
Class II
Regulation
21 CFR Part 870.4875
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Transluminal Endarterectomy Device is a cardiovascular device used for performing endarterectomy procedures. It is designed to remove plaque from the inside of arteries through a transluminal approach.

This device is manufactured by Baxter Healthcare Corp and is classified under product code DWX. It received FDA 510(k) clearance on December 17, 1990, with the K number K904944, and is classified as substantially equivalent. The device is intended for single use and is regulated under FDA regulation number 870.4875.

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Questions

AI-generated answers, 1 Oct 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 Transluminal Endarterectomy Device used for?

    The Transluminal Endarterectomy Device is a cardiovascular device designed to remove plaque from the inside of arteries through a transluminal approach, facilitating endarterectomy procedures.

  • Is the Transluminal Endarterectomy Device reusable or single-use?

    The Transluminal Endarterectomy Device is intended for single use only, as specified in its regulatory classification, ensuring safety and preventing cross-contamination between patients.

  • What regulatory approvals does the Transluminal Endarterectomy Device have?

    The device received FDA 510(k) clearance on December 17, 1990, with K number K904944, and is classified as substantially equivalent under FDA regulation number 870.4875.

  • What is the product classification of the Transluminal Endarterectomy Device?

    The device is classified under product code DWX and is categorized as a Class II medical device with a medical specialty description of Cardiovascular.