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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, steerable
510(k) Number K202620
Device Name FlexCath Advance Steerable Sheath and Dilator
Applicant
Medtronic CryoCath LP
8200 Coral Sea Street NE, MVS 46
Mounds View,  MN  55112
Applicant Contact Matthew Lobeck
Correspondent
Medtronic CryoCath LP
8200 Coral Sea Street NE, MVS 46
Mounds View,  MN  55112
Correspondent Contact Matthew Lobeck
Regulation Number870.1280
Classification Product Code
DRA  
Date Received09/10/2020
Decision Date 11/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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