Medical Devices; Neurological Devices; Classification of the Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment
fda-device · Food and Drug Administration · Rule · Published 2016-12-23 · Effective 2016-12-23 · 81 FR 94251
Document
Document number
2016-31007
Federal Register citation
81 FR 94251
CFR reference
21 CFR 882
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2016-12-23
Effective date
2016-12-23
HHS docket
Docket No. FDA-2016-N-4165
Abstract
The Food and Drug Administration (FDA) is classifying the neurovascular mechanical thrombectomy device for acute ischemic stroke treatment into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the neurovascular mechanical thrombectomy device for acute ischemic stroke treatment's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.