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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Test, Heart-Valve
510(k) Number K881449
Device Name EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116
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 Number870.4500
Classification Product Code
LXN  
Date Received04/05/1988
Decision Date 06/15/1988
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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