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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 K132720
Device Name HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
Applicant
MERIT MEDICAL SYSTEMS, INC.
65 GREAT VALLEY PAKRWAY
MALVERN,  PA  19355
Applicant Contact ALINA STUBBS
Correspondent
MERIT MEDICAL SYSTEMS, INC.
65 GREAT VALLEY PAKRWAY
MALVERN,  PA  19355
Correspondent Contact ALINA STUBBS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/30/2013
Decision Date 02/12/2014
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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