Hansen Medical Magellan Robotic Catheter 9Fr

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 9fr.

Pre-market Notification Details

Device IDK160919
510k NumberK160919
Device Name:Hansen Medical Magellan Robotic Catheter 9Fr
ClassificationCatheter, Steerable
Applicant HANSEN MEDICAL, INC. 800 E MIDDLEFIELD ROAD Mountain View,  CA  94043
ContactMarysa Loustalot
CorrespondentMarysa Loustalot
HANSEN MEDICAL, INC. 800 E MIDDLEFIELD ROAD Mountain View,  CA  94043
Product CodeDRA  
CFR Regulation Number870.1280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-04
Decision Date2016-09-20
Summary:summary

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