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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 K172117
Device Name Prelude Pursuit Splittable Sheath Introducer
Applicant
Merit Medical Systems, Inc.
65 Great Valley Pkwy.
Malvern,  PA  19355
Applicant Contact Jacquelyn Huyghue
Correspondent
Merit Medical Systems, Inc.
65 Great Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact Jacquelyn Huyghue
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/13/2017
Decision Date 09/11/2017
Decision Substantially Equivalent - Kit (SESK)
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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