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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(K) Number K120459
Device Name STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
Applicant
OSCOR INC.
3816 de soto blvd.
palm harbor,  FL  34683
Contact mila doskocil
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/15/2012
Decision Date 06/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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