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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 K230156
Device Name 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
Applicant
Medtronic Vascular
37A Cherry Hill Drive
Danvers,  MA  01923
Applicant Contact Shalin Parikh
Correspondent
Medtronic Vascular
37A Cherry Hill Drive
Danvers,  MA  01923
Correspondent Contact Shalin Parikh
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/19/2023
Decision Date 06/30/2023
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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