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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 K143255
Device Name Prelude SNAP Splittable Sheath Introducer
Applicant
Merit Medical Systems, Inc.
65 Great Valley Pkwy.
Malvern,  PA  19355
Applicant Contact Alina Stubbs
Correspondent
Merit Medical Systems, Inc.
65 Great Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact Alina Stubbs
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/13/2014
Decision Date 04/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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