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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Pump, Cardiopulmonary Bypass
510(k) Number K092486
Device Name VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
Applicant
Vortex Medical, Inc.
42 Horicon Ave.
Glens Falls,  NY  12801
Applicant Contact BRIAN KUNST
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131 -1230
Correspondent Contact MORTEN S CHRISTENSEN
Regulation Number870.4390
Classification Product Code
DWE  
Date Received08/13/2009
Decision Date 08/28/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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