FDA 510(k)

Rayvolve PTX-PE

K-Number: K243808 · 2025-03-21

ApplicantAZmed

Decision Date2025-03-21

Product CodeQFM

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Rayvolve PTX-PE is the device name listed in this FDA 510(k) record. The listed applicant is AZmed. It received FDA 510(k) clearance on 2025-03-21 under 510(k) number K243808. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rayvolve PTX-PE?

Rayvolve PTX-PE is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is AZmed. The 510(k) number is K243808.

When did Rayvolve PTX-PE receive FDA 510(k) clearance?

Rayvolve PTX-PE received FDA 510(k) clearance on 2025-03-21, under 510(k) number K243808.

Who is the listed applicant for Rayvolve PTX-PE?

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

What is the FDA product code for Rayvolve PTX-PE?

The FDA product code for Rayvolve PTX-PE is QFM.

Other records listing AZmed 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.

K260378Rayvolve K243831Rayvolve LN

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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.