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976745

Circulatory Technology Inc. — FEI 1000522036

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 8, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Oyster Bay, NY (United States)

Facility

Other inspections at this facility

  • 1111775 (VAI Wed Dec 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067277 (OAI Wed Sep 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 936945 (VAI Fri Jul 31 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 822890 (NAI Mon Mar 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 723898 (NAI Mon Apr 25 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
243021 CFR 820.30(b)Design plans - Lack of or inadequate
263021 CFR 820.30(e)Design review - documentation
310421 CFR 820.30(j)Design history file
317221 CFR 820.198(c)Investigation of device failures
319021 CFR 820.30(g)Design validation acceptance criteria
326621 CFR 820.86Acceptance status
342621 CFR 820.50(a)(1)Documented evaluation
369621 CFR 820.100(b)Documentation
64821 CFR 803.18(e)MDR not evaluated per 820.198
73221 CFR 803.50(a)(2)Individual Report of Malfunction