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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 K130559
Device Name MOBICATH BI-DIRECTIONAL GUIDING SHEATH
Applicant
Greatbatch Medical
2300 BERKSHIRE LANE NORTH
MINNEAPOLIS,  MN  55441
Applicant Contact DENISE THOMPSON
Correspondent
Greatbatch Medical
2300 BERKSHIRE LANE NORTH
MINNEAPOLIS,  MN  55441
Correspondent Contact DENISE THOMPSON
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/04/2013
Decision Date 05/24/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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