The Food and Drug Administration medical device review process: clearance of a clot retriever for use in ischemic stroke

Stroke. 2005 Feb;36(2):404-6. doi: 10.1161/01.STR.0000153063.54972.91. Epub 2004 Dec 29.

Authors

Richard P Felten¹, Neil R P Ogden, Carlos Peña, Miriam C Provost, Michael J Schlosser, Celia M Witten

Affiliation

¹ 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.

PMID: 15625290
DOI: 10.1161/01.STR.0000153063.54972.91

No abstract available

MeSH terms

Brain Ischemia / surgery*
Brain Ischemia / therapy
Catheterization / instrumentation
Catheterization / standards
Clinical Trials as Topic
Device Approval
Embolectomy / instrumentation*
Embolectomy / methods
Embolectomy / standards
Equipment Safety
Humans
Intracranial Embolism / surgery*
Stroke / surgery*
Stroke / therapy
United States
United States Food and Drug Administration