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FDA 510(k)

Aline Ablation Intelligence

K-Number: K202297 · 2020-09-11

ApplicantMirada Medical, Ltd.
Decision Date2020-09-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aline Ablation Intelligence is the device name listed in this FDA 510(k) record. The listed applicant is Mirada Medical, Ltd.. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K202297. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aline Ablation Intelligence?

Aline Ablation Intelligence is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Mirada Medical, Ltd.. The 510(k) number is K202297.

When did Aline Ablation Intelligence receive FDA 510(k) clearance?

Aline Ablation Intelligence received FDA 510(k) clearance on 2020-09-11, under 510(k) number K202297.

Who is the listed applicant for Aline Ablation Intelligence?

The FDA 510(k) record lists Mirada Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aline Ablation Intelligence?

The FDA product code for Aline Ablation Intelligence is LLZ.

Other records listing Mirada Medical, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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