Medical Devices; Cardiovascular Devices; Classification of the Steerable Cardiac Ablation Catheter Remote Control System
fda-device · Food and Drug Administration · Rule · Published 2015-09-30 · Effective 2015-09-30 · 80 FR 58603
Document
Document number
2015-24624
Federal Register citation
80 FR 58603
CFR reference
21 CFR 870
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2015-09-30
Effective date
2015-09-30
HHS docket
Docket No. FDA-2015-N-3165
Abstract
The Food and Drug Administration (FDA) is classifying the steerable cardiac ablation catheter remote control system 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 steerable cardiac ablation catheter remote control system'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.