Scimed Ultrox True Membrane Oxygen Syst, Ultrox II

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K894103 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K933183 Active Cleared 9 Sep 1993

• Scimed 7Fr and 8Fr Triguide Guiding Catheters

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  FDA 510(k) K914312 Active Cleared 22 Nov 1991

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• Scimed Pursuit Exchange Ptca Guide Wire

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• Scimed(R) Controlwire(Tm) Guide Wire

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  FDA 510(k) K914194 Active Cleared 9 Jun 1992

See all devices from Scimed Life Systems, Inc. →

• What is the primary clinical purpose of the Ultrox True Membrane Oxygen System, Ultrox II, and where is it typically used?

  The Ultrox True Membrane Oxygen System, Ultrox II, is designed specifically for cardiopulmonary bypass procedures to facilitate gas exchange between blood and a gaseous environment. This ensures oxygenation of the blood and removal of carbon dioxide during open-heart surgeries. It is intended for use in controlled clinical settings such as operating rooms and cardiac catheterization labs, where extracorporeal circulation is required to support a patient’s physiological needs during surgery.

• Is the Ultrox True Membrane Oxygen System reusable or single-use, and what does this mean for maintenance and handling?

  The Ultrox True Membrane Oxygen System is supplied as a reusable medical device. This means it is designed to be cleaned, disinfected, and reused for multiple procedures, provided it is maintained according to manufacturer guidelines. Reusability requires adherence to strict protocols for sterilization and maintenance to ensure safety and functionality between uses.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?

  The Ultrox True Membrane Oxygen System received FDA clearance through a 510(k) submission, classified as Traditional, under the product code DTZ and regulated under FDA regulation number 870.4350. The device was reviewed by the Cardiovascular (CV) Advisory Committee, which provides expert input on cardiovascular-related medical devices before clearance decisions.

• Are there multiple models or sizes available for this oxygenator system, and how would a buyer determine the correct fit for their needs?

  The Ultrox True Membrane Oxygen System includes multiple FEI numbers (e.g., 3030125051, 3021599320, etc.), which likely correspond to different configurations, sizes, or variants of the device. These variations may cater to different patient sizes, blood flow requirements, or procedural needs. Buyers should consult the manufacturer’s documentation or a medical device specialist to select the appropriate model based on clinical requirements, such as oxygenation capacity and compatibility with existing cardiopulmonary bypass systems.

• How should the Ultrox True Membrane Oxygen System be stored, and are there any specific storage conditions mentioned in the available data?

  The provided data does not specify detailed storage conditions such as temperature, humidity, or shelf-life requirements for the Ultrox True Membrane Oxygen System. However, as a reusable medical device, it should be stored in a clean, dry environment, protected from contamination and physical damage. Manufacturers typically provide storage instructions in their technical documentation, which should be followed to maintain device integrity and functionality.