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K Number
K143227

Validate with FDA (Live)

Device Name
Magellan Robotic System, Magellan Robotic Catheter 10Fr
Manufacturer
HANSEN MEDICAL, INC.
Date Cleared
2015-07-01

(233 days)

Product Code
DXX
Regulation Number
870.1290
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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§ 870.1290 Steerable catheter control system.

(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).