Overview of Cardiopulmonary Bypass Pre-Bypass Filters
What Are Cardiopulmonary Bypass Pre-Bypass Filters?
A cardiopulmonary prebypass filter is a device used during priming of the oxygenator circuit to remove particulates or other debris from the circuit prior to initiating bypass. The device is not used to filter blood.
Cardiopulmonary Bypass Pre-Bypass Filters Classification
- Medical specialty: Cardiovascular Devices
- Medical usage: Cardiovascular Surgical Devices
- Product group: Cardiopulmonary Bypass Equipment
- FDA device type designation: Cardiopulmonary Bypass Pre-Bypass Filters
- Corresponding Regulation Number: 870.4280
- Device Class: 2 - Cardiopulmonary Bypass Pre-Bypass Filters are subject to General Controls and Special Controls
- GMP Exemption: Cardiopulmonary Bypass Pre-Bypass Filters are not exempt from Good Manufacturing
- Third Party Status: Cardiopulmonary Bypass Pre-Bypass Filters are eligible for Accredited Persons Expansion Pilot Program
- Submission type: 510(k)
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