SENSEI X ROBOTIC CATHETER SYSTEM— 510(k) K102168

Substantially Equivalent

Hansen Medical, Inc.

FDA 510(k) clearance K102168 for SENSEI X ROBOTIC CATHETER SYSTEM, Substantially Equivalent on 2010-10-22. Applicant: Hansen Medical, Inc..

Clearance details

Applicant: Hansen Medical, Inc.
Product code: 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

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