SENSEI X ROBOTIC CATHETER SYSTEM

System, Catheter Control, Steerable

HANSON MEDICAL, INC.

The following data is part of a premarket notification filed by Hanson Medical, Inc. with the FDA for Sensei X Robotic Catheter System.

Pre-market Notification Details

Device IDK141822
510k NumberK141822
Device Name:SENSEI X ROBOTIC CATHETER SYSTEM
ClassificationSystem, Catheter Control, Steerable
Applicant HANSON MEDICAL, INC. 800 EAST MIDDLEFIELD RD Mountain View,  CA  94043
ContactTodd Milholland
CorrespondentTodd Milholland
HANSON MEDICAL, INC. 800 EAST MIDDLEFIELD RD Mountain View,  CA  94043
Product CodeDXX  
CFR Regulation Number870.1290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-07
Decision Date2014-08-05
Summary:summary

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