Home / Compliance actions / 491979

Warning Letter

Case 491979 — FEI 3007284006

Facility

Recent inspections

  • 1083024 (NAI Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026732 (NAI Wed Sep 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 956408 (OAI Thu Jan 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 825660 (NAI Thu Mar 14 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754488 (NAI Wed Nov 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Spectranetics Corporation
Date
May 23, 2016
Fiscal Year
2016
Product Type
Devices
Center
CDRH
Location
Colorado Springs, CO (United States)