K102168

Substantially Equivalent

SENSEI X ROBOTIC CATHETER SYSTEM

Applicant: Hansen Medical, Inc.
Product code: DXX
Advisory panel: Cardiovascular
Date received: 2010-08-02
Decision date: 2010-10-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.