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K Number
K232321

Validate with FDA (Live)

Device Name
FlexCath Contour™ Steerable Sheath
Manufacturer
Medtronic Inc.
Date Cleared
2023-10-31

(89 days)

Product Code
DRA
Regulation Number
870.1280
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 870.1280 Steerable catheter.

(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).