Home / Inspections / 841494

841494

Medtronic Vascular, Inc. — FEI 3005364322

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 4, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Santa Rosa, CA (United States)

Facility

Other inspections at this facility

  • 1026763 (NAI Fri Sep 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 976758 (NAI Tue Apr 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 968311 (NAI Thu Jan 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 595178 (NAI Fri Jun 19 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
419121 CFR 806.10(a)(1)Report of risk to health
73321 CFR 803.50(b)(1)Reporting Information Reasonably Known