FDA 510(k), K171332, Artemis Neuro Evacuation Device

FDA 510(k), K171332, Artemis Neuro Evacuation Device

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510(K) Number: K171332
Device Name: Artemis Neuro Evacuation Device
Manufacturer: Penumbra, Inc.
Device Classification Name: Endoscope, Neurological
Regulation Number: 882.1480
Classification Product Code: GWG
Date Received: 05/08/2017
Decision Date: 08/14/2017
Regulation Medical Specialty: Neurology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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