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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K063293
Device Name EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE
Applicant
Edwards Lifesciences Services GmbH
Business & Technology Center
Bessemer Dr.
Stevenage,  GB SG1 2DX
Applicant Contact NEIL R ARMSTRONG
Correspondent
Edwards Lifesciences Services GmbH
Business & Technology Center
Bessemer Dr.
Stevenage,  GB SG1 2DX
Correspondent Contact NEIL R ARMSTRONG
Regulation Number876.5820
Classification Product Code
FJK  
Date Received11/01/2006
Decision Date 03/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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