FDA 510(k)

cmAngio® V2.0

K-Number: K260980 · 2026-07-30

Decision Date2026-07-30

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

cmAngio® V2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Curemetrix, Inc.. It received FDA 510(k) clearance on 2026-07-30 under 510(k) number K260980. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cmAngio® V2.0?

cmAngio® V2.0 is a medical device that received FDA 510(k) clearance on 2026-07-30. The listed applicant is Curemetrix, Inc.. The 510(k) number is K260980.

When did cmAngio® V2.0 receive FDA 510(k) clearance?

cmAngio® V2.0 received FDA 510(k) clearance on 2026-07-30, under 510(k) number K260980.

Who is the listed applicant for cmAngio® V2.0?

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

What is the FDA product code for cmAngio® V2.0?

The FDA product code for cmAngio® V2.0 is QIH.

Other records listing Curemetrix, 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.

K250754cmAngio® (V1.6)K232367cmAngio® V1.0 K183285cmTriage

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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.