Hansen Medical, Inc. - Oct. 16, 2014
Issue Date
Oct 16, 2014
Region
Pacific
Category
Device
$117.00
Contact Name
Cary G. Vance
Contact Title
President and Chief Executive Officer
Address 1
800 E. Middlefield Rd.
City
Mountain View
State
CA
Zip/Postal Code
94043-4030
Country
United States
Inspection Range
Oct 07, 2014 - Oct 16, 2014
Pages
2
First Observation
And MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Investigator(s): Mary R. Hole