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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K091304
Device Name VORTEX CANNULA
Applicant
Vortex Medical, Inc.
50 Loring Dr.
Norwell,  MA  02061
Applicant Contact CHERYL BLAKE
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131
Correspondent Contact MORTEN CHRISTENSEN
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/04/2009
Decision Date 07/02/2009
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
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