Hansen Medical Magellan Robotic Catheter EKit

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 Ekit.

Pre-market Notification Details

Device IDK153304
510k NumberK153304
Device Name:Hansen Medical Magellan Robotic Catheter EKit
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 Received2015-11-16
Decision Date2016-02-01
Summary:summary

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