Magellan Robotic System, Magellan Robotic Catheter 10Fr— 510(k) K143227

Name: FDA 510(k) clearance K143227
Creator: U.S. Food and Drug Administration
Published: 2015-07-01

Substantially Equivalent

Hansen Medical, Inc.

FDA 510(k) clearance K143227 for Magellan Robotic System, Magellan Robotic Catheter 10Fr, Substantially Equivalent on 2015-07-01. Applicant: Hansen Medical, Inc.. Device class: 2.

Clearance details

Applicant: Hansen Medical, Inc.
Product code: Code DXX
Device class: Class 2
Regulation: 21 CFR 870.1290
Advisory panel: Cardiovascular
Date received: 2014-11-10
Decision date: 2015-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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