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Oxygenation Catheter

by Ventech Healthcare Corp., Inc.

510(k) K881881

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK881881 Date17 Feb 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
BTM
Device Class
Class II
Regulation
21 CFR Part 868.5915
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Oxygenation Catheter is a medical device classified under product code BTM for use in anesthesiology. It is designed to facilitate oxygenation during medical procedures.

This device is supplied by Ventech Healthcare Corp., Inc. and received FDA 510(k) clearance on February 17, 1989, with the decision code SESE. The Oxygenation Catheter is regulated under number 868.5915 and is classified as a Class II device.

Questions

AI-generated answers, 25 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 Oxygenation Catheter used for?

    The Oxygenation Catheter is a medical device designed to facilitate oxygenation during medical procedures in anesthesiology. It helps maintain proper oxygen levels during patient care.

  • How is the Oxygenation Catheter supplied?

    The Oxygenation Catheter is supplied by Ventech Healthcare Corp., Inc. It is classified under product code BTM and is designed for use in anesthesiology procedures to ensure proper oxygenation.

  • What is the regulatory status of the Oxygenation Catheter?

    The Oxygenation Catheter received FDA 510(k) clearance on February 17, 1989, with decision code SESE. It is regulated under number 868.5915 and classified as a Class II device.

  • Is the Oxygenation Catheter single-use or reusable?

    The device data does not specify whether the Oxygenation Catheter is single-use or reusable. This information would need to be obtained directly from the manufacturer or product documentation.