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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 K232321
Device Name FlexCath Contour™ Steerable Sheath
Applicant
Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Applicant Contact Kripa Pandya
Correspondent
Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Correspondent Contact Kripa Pandya
Regulation Number870.1280
Classification Product Code
DRA  
Date Received08/03/2023
Decision Date 10/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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