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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 K122958
Device Name DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
Applicant
Oscor Inc.
3816 DE SOTO BLVD.
PALM HARBOR,  FL  34683
Applicant Contact MILA DOSKOCIL
Correspondent
Oscor Inc.
3816 DE SOTO BLVD.
PALM HARBOR,  FL  34683
Correspondent Contact MILA DOSKOCIL
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/25/2012
Decision Date 12/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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