Hansen Medical Magellan Robotic Catheter 6Fr And Accessory Components

Catheter, Steerable

HANSEN MEDICAL, INC.

The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Hansen Medical Magellan Robotic Catheter 6fr And Accessory Components.

Pre-market Notification Details

Device IDK151463
510k NumberK151463
Device Name:Hansen Medical Magellan Robotic Catheter 6Fr And Accessory Components
ClassificationCatheter, Steerable
Applicant HANSEN MEDICAL, INC. 800 E. MIDDLEFIELD ROAD Mountain View,  CA  94043
ContactElisa Aldridge
CorrespondentElisa Aldridge
HANSEN MEDICAL, INC. 800 E. MIDDLEFIELD ROAD Mountain View,  CA  94043
Product CodeDRA  
CFR Regulation Number870.1280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-01
Decision Date2015-08-18
Summary:summary

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