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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stabilizer, Heart
510(k) Number K992833
FOIA Releasable 510(k) K992833
Device Name VACUUM ASSIST STABILIZER
Applicant
Cardio Thoracic Systems
10600 N. Tantau Ave.
Cupertino,  CA  95014
Applicant Contact Michael Billig
Correspondent
Cardio Thoracic Systems
10600 N. Tantau Ave.
Cupertino,  CA  95014
Correspondent Contact Michael Billig
Regulation Number870.4500
Classification Product Code
MWS  
Date Received08/23/1999
Decision Date 11/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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