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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 K003880
Device Name CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)
Applicant
CONCENTRIC MEDICAL, INC.
2585 LEGHORN ST.
MOUTIAN VIEW,  CA  94043
Applicant Contact SAM LAZZARA
Correspondent
CONCENTRIC MEDICAL, INC.
2585 LEGHORN ST.
MOUTIAN VIEW,  CA  94043
Correspondent Contact SAM LAZZARA
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/15/2000
Decision Date 05/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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