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FDA 510(k)

Isolator Synergy EnCapture Ablation System (EMH)

K-Number: K234151 · 2024-08-27

ApplicantAtriCure, Inc.
Decision Date2024-08-27
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Isolator Synergy EnCapture Ablation System (EMH) is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2024-08-27 under approval number K234151. 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 Isolator Synergy EnCapture Ablation System (EMH)?

Isolator Synergy EnCapture Ablation System (EMH) is a medical device that received FDA 510(k) clearance on 2024-08-27. It is manufactured by AtriCure, Inc.. The 510(k) number is K234151.

When was Isolator Synergy EnCapture Ablation System (EMH) approved by the FDA?

Isolator Synergy EnCapture Ablation System (EMH) received FDA 510(k) clearance on 2024-08-27, under approval number K234151.

What company makes Isolator Synergy EnCapture Ablation System (EMH)?

Isolator Synergy EnCapture Ablation System (EMH) is manufactured by AtriCure, Inc..

What is the FDA product code for Isolator Synergy EnCapture Ablation System (EMH)?

The FDA product code for Isolator Synergy EnCapture Ablation System (EMH) 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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