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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 K192296
Device Name Medtronic 6F Taiga Guiding Catheter
Applicant
Medtronic Vascular
37a Cherry Hill Drive
Danvers,  MA  01923
Applicant Contact Colleen Mullins
Correspondent
Medtronic Vascular
37a Cherry Hill Drive
Danvers,  MA  01923
Correspondent Contact Colleen Mullins
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/23/2019
Decision Date 09/20/2019
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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