510(k) K092486

VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT by Vortex Medical, Inc. — Product Code DWE

K092486 is an FDA 510(k) premarket notification submitted by Vortex Medical, Inc. for the device "VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT". The FDA issued a decision of Substantially Equivalent on August 28, 2009. The device falls under product code DWE (Tubing, Pump, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4390. Vortex Medical, Inc. has at least 2 other 510(k) clearances on record.