Integrated Membrane Oxygenator W/Cardiotomy Filter

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

510(k) Number

K873923 ↗

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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• What is the primary function of this device?

  The Integrated Membrane Oxygenator W/Cardiotomy Filter functions as an oxygenator during cardiopulmonary bypass procedures. It facilitates gas exchange to support respiratory function during surgery.

• Is this device intended for single use?

  Yes, this device is supplied as a single-use item and is not reusable. Proper storage and handling are required to maintain sterility.

• What regulatory clearance does this device have?

  This device is regulated under FDA 510(k) clearance. It was determined to be substantially equivalent to a predicate device.

• How should the device be stored and handled?

  Proper storage and handling are required to maintain sterility. The device is intended for use in cardiovascular procedures.