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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 K211405
Device Name Prelude Guide Sheath
Applicant
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan,  UT  84095
Applicant Contact David Thomas
Correspondent
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan,  UT  84095
Correspondent Contact David Thomas
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Code
DRE  
Date Received05/06/2021
Decision Date 10/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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