K Number
K002591Device Name
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
Manufacturer
Date Cleared
2000-09-13
(23 days)
Product Code
Regulation Number
870.4230AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information
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§ 870.4230 Cardiopulmonary bypass defoamer.
(a)
Identification. A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.”
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