FDA Inspection 1305774 - Helios Cardio Inc. - March 06, 2026

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Record Details

This FDA Inspection record concerns Helios Cardio Inc., with an inspection on March 6, 2026, issued by the Center for Devices and Radiological Health, covering devices.

Company: Helios Cardio Inc.
Inspection Date: March 6, 2026
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 58f7bb5f-6b29-43f9-bd2c-2282a9e6ec59

Violation Codes1

ISO 13485:2016 Clause 4.1.5

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