FDA 510(k)

Arterys Cardio DL

K-Number: K163253 · 2017-01-05

Decision Date2017-01-05

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Arterys Cardio DL is the device name listed in this FDA 510(k) record. The listed applicant is Arterys, Inc.. It received FDA 510(k) clearance on 2017-01-05 under 510(k) number K163253. 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 Arterys Cardio DL?

Arterys Cardio DL is a medical device that received FDA 510(k) clearance on 2017-01-05. The listed applicant is Arterys, Inc.. The 510(k) number is K163253.

When did Arterys Cardio DL receive FDA 510(k) clearance?

Arterys Cardio DL received FDA 510(k) clearance on 2017-01-05, under 510(k) number K163253.

Who is the listed applicant for Arterys Cardio DL?

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

What is the FDA product code for Arterys Cardio DL?

The FDA product code for Arterys Cardio DL is LLZ.

Other records listing Arterys, Inc. 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.