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510(k) K232321

FlexCath Contour™ Steerable Sheath by Medtronic, Inc. — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2023
Date Received
August 3, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Steerable
Device Class
Class II
Regulation Number
870.1280
Review Panel
CV
Submission Type

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