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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 K212152
Device Name Prelude IDeal 9F Hydrophilic Sheath Introducer
Applicant
Merit Medical Systems
1600w Merit Pkwy.
South Jordan,  UT  84095
Applicant Contact David Thomas
Correspondent
Merit Medical Systems
1600w Merit Pkwy.
South Jordan,  UT  84095
Correspondent Contact David Thomas
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/09/2021
Decision Date 01/07/2022
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
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