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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, steerable
510(k) Number K120086
Device Name CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM
Original Applicant
CARDIOSOLUTIONS
375 west st.
west bridgewater,  MA  02379
Original Contact michele lucey
Regulation Number870.1280
Classification Product Code
DRA  
Subsequent Product Code
DYB  
Date Received01/11/2012
Decision Date 04/24/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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