HANSEN MEDICAL ARTISAN S CONTROL CATHETER

System, Catheter Control, Steerable

HANSEN MEDICAL, INC.

The following data is part of a premarket notification filed by Hansen Medical, Inc. with the FDA for Hansen Medical Artisan S Control Catheter.

Pre-market Notification Details

Device IDK090365
510k NumberK090365
Device Name:HANSEN MEDICAL ARTISAN S CONTROL CATHETER
ClassificationSystem, Catheter Control, Steerable
Applicant HANSEN MEDICAL, INC. 800 E. MIDDLEFIELD ROAD Mountain View,  CA  94043
ContactKate Whitin
CorrespondentKate Whitin
HANSEN MEDICAL, INC. 800 E. MIDDLEFIELD ROAD Mountain View,  CA  94043
Product CodeDXX  
CFR Regulation Number870.1290 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-13
Decision Date2009-05-07
Summary:summary

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