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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
Applicant
CARDIOSOLUTIONS
375 west st.
west bridgewater,  MA  02379
Applicant Contact michele lucey
Correspondent
CARDIOSOLUTIONS
375 west st.
west bridgewater,  MA  02379
Correspodent 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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