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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K232190
Device Name 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
Applicant
Medtronic Vascular
37A Cherry Hill Drive
Danvers,  MA  01923
Applicant Contact Colleen Gentile
Correspondent
Medtronic Vascular
37A Cherry Hill Drive
Danvers,  MA  01923
Correspondent Contact Colleen Gentile
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/24/2023
Decision Date 08/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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