Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System
fda-device · Food and Drug Administration · Rule · Published 2012-02-14 · Effective 2012-03-15 · 77 FR 8117
Document
Document number
2012-3398
Federal Register citation
77 FR 8117
CFR reference
21 CFR 870
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2012-02-14
Effective date
2012-03-15
HHS docket
Docket No. FDA-2012-N-0091
Abstract
The Food and Drug Administration (FDA) is classifying the endovascular suturing system into class II (special controls). 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.