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Product safetyFDAUnited StatesImports

Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures

10 September 2026

In plain English

FDA is classifying the mechanical deviation device for esophageal protection during cardiac ablation procedures into class II, subject to identified special controls.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
10 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA) is classifying the mechanical deviation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the mechanical deviation device for esophageal protection during cardiac ablation procedures. We are taking this action because we have determined that classifying the devi
The full text is at the source

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