Cobe CMS-HF Hollow Fiber Membrane Oxygenator

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

510(k) Number

K923272 ↗

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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  Class II

  FDA 510(k) K790546 Active Cleared 11 May 1979

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  Class II

  FDA 510(k) K812336 Active Cleared 31 Aug 1981

• Cobe Spectra Blood Component Separator Therapeutic

  Unclassified

  FDA 510(k) K900105 Active Cleared 22 Mar 1991

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  FDA 510(k) K842138 Active Cleared 3 Aug 1984

• Centry 2 Ultrafiltration Control Kit, #018762-002

  Class II

  FDA 510(k) K881062 Active Cleared 21 Apr 1988

• Cobe Rx Meter

  Class II

  FDA 510(k) K830629 Active Cleared 6 Apr 1983

See all devices from Cobe Laboratories, Inc. →

• What is the Cobe CMS-HF Hollow Fiber Membrane Oxygenator used for?

  This device is designed for gas exchange during extracorporeal circulation, specifically providing oxygenation and carbon dioxide removal for patients undergoing cardiac surgery or procedures requiring temporary circulatory support. Its hollow fiber membrane structure allows efficient diffusion of oxygen into and carbon dioxide out of the patient’s blood, maintaining physiological gas levels while the heart is bypassed.

• Is the Cobe CMS-HF Hollow Fiber Membrane Oxygenator intended for single-use or reuse?

  The device is explicitly supplied as a disposable component for single-use applications. This design ensures compliance with infection control protocols and maintains sterility, which is critical in controlled clinical settings like operating rooms and cardiac catheterization labs.

• How should the Cobe CMS-HF Hollow Fiber Membrane Oxygenator be stored before use?

  Storage and handling must follow the manufacturer’s guidelines to preserve both functionality and sterility. Since it is a single-use device, it should remain in its sterile packaging until deployment. Proper storage conditions prevent contamination and ensure the device performs as intended during cardiac procedures.

• What regulatory clearance does the Cobe CMS-HF Hollow Fiber Membrane Oxygenator hold?

  The device holds a 510(k) clearance (K923272) from the FDA under regulation 870.4350, classified as substantially equivalent to a predicate device. It is categorized as FDA Class II and was reviewed by the Cardiovascular Advisory Committee. No third-party involvement was required for its clearance.

• Where can the Cobe CMS-HF Hollow Fiber Membrane Oxygenator be used?

  This device is intended for use in operating rooms and cardiac catheterization labs where extracorporeal circulation is required. Its sterile, single-use design makes it suitable for controlled clinical environments where maintaining patient safety and infection control are priorities.