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FDA 510(k)

COBRA Fusion Ablation System

K-Number: K190151 · 2019-02-25

ApplicantAtriCure, Inc.
Decision Date2019-02-25
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COBRA Fusion Ablation System is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2019-02-25 under approval number K190151. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBRA Fusion Ablation System?

COBRA Fusion Ablation System is a medical device that received FDA 510(k) clearance on 2019-02-25. It is manufactured by AtriCure, Inc.. The 510(k) number is K190151.

When was COBRA Fusion Ablation System approved by the FDA?

COBRA Fusion Ablation System received FDA 510(k) clearance on 2019-02-25, under approval number K190151.

What company makes COBRA Fusion Ablation System?

COBRA Fusion Ablation System is manufactured by AtriCure, Inc..

What is the FDA product code for COBRA Fusion Ablation System?

The FDA product code for COBRA Fusion Ablation System is OCL.

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Related Devices (Code: OCL)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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