The Food and Drug Administration medical device review process: clearance of a clot retriever for use in ischemic stroke.
Felten
Richard P
RP
Division of General, Restorative, and Neurological Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Md 20815, USA.
Ogden
Neil R P
NR
Peña
Carlos
C
Provost
Miriam C
MC
Schlosser
Michael J
MJ
Witten
Celia M
CM
D002545:Brain Ischemia / Q000601:surgery* / Q000628:therapy; D002404:Catheterization / Q000295:instrumentation / Q000592:standards; D002986:Clinical Trials as Topic; D018795:Device Approval; D017128:Embolectomy / Q000295:instrumentation* / Q000379:methods / Q000592:standards; D004869:Equipment Safety; D006801:Humans; D020766:Intracranial Embolism / Q000601:surgery*; D020521:Stroke / Q000601:surgery* / Q000628:therapy; D014481:United States; D014486:United States Food and Drug Administration