FDA Inspection
Medtronic Vascular, Inc.Medtronic Vascular, Inc. – FDA Inspection, Sep 4, 2013
Record Details
This FDA Inspection record concerns Medtronic Vascular, Inc., with an inspection on September 4, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medtronic Vascular, Inc.
- Inspection Date
- September 4, 2013
- Product Type
- Devices
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ID · cb819a59-228e-4bc4-8001-7dc3d7aeb47c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 841494
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Medtronic Vascular, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 19, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 21, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 19, 2009 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Medtronic Vascular, Inc.
- FDA Inspection 1026763 - 2017-09-08
- FDA Inspection 976758 - 2016-04-19
- FDA Inspection 968311 - 2016-01-21
- FDA Inspection 595178 - 2009-06-19
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