FDA Inspection
Hansen Medical IncHansen Medical Inc – FDA Inspection, Oct 16, 2014
Record Details
This FDA Inspection record concerns Hansen Medical Inc, with an inspection on October 16, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hansen Medical Inc
- Inspection Date
- October 16, 2014
- Product Type
- Devices
View Company Profile
ID · cf5f18ca-3562-476e-819c-7a5cfa09fa26
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 899020
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hansen Medical Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 3, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 28, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hansen Medical Inc
- FDA Inspection 988550 - 2016-08-29
- FDA Inspection 941902 - 2015-09-03
- FDA Inspection 669351 - 2010-06-28
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