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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K111154
Device Name SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
Original Applicant
6024 jean road
lake oswego,  OR  97035
Original Contact jon brumbaugh
Regulation Number870.1250
Classification Product Code
Subsequent Product Code
Date Received04/25/2011
Decision Date 05/23/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No