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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sizer, Heart-Valve, Prosthesis
510(k) Number K881279
Device Name EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
Applicant
Baxter Healthcare Corp
P O Box 11150
Santa Ana,  CA  92711
Applicant Contact JOHN L ELY
Correspondent
Baxter Healthcare Corp
P O Box 11150
Santa Ana,  CA  92711
Correspondent Contact JOHN L ELY
Regulation Number870.3945
Classification Product Code
DTI  
Date Received03/22/1988
Decision Date 05/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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