HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER— 510(k) K111004

Substantially Equivalent

Hansen Medical, Inc.

FDA 510(k) clearance K111004 for HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER, Substantially Equivalent on 2012-05-29. Applicant: Hansen Medical, Inc..

Clearance details

Applicant: Hansen Medical, Inc.
Product code: Code DXX
Advisory panel: Cardiovascular
Date received: 2011-04-11
Decision date: 2012-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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