SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057

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 Sensei Robotic Catheter System, Model 02057.

Pre-market Notification Details

Device IDK091808
510k NumberK091808
Device Name:SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057
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 Received2009-06-18
Decision Date2009-09-10
Summary:summary

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