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 a medical device manufactured by AZmed. It received FDA 510(k) clearance on 2025-03-21 under approval 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. It is manufactured by AZmed. The 510(k) number is K243808.
When was Rayvolve PTX-PE approved by the FDA?
Rayvolve PTX-PE received FDA 510(k) clearance on 2025-03-21, under approval number K243808.
What company makes Rayvolve PTX-PE?
Rayvolve PTX-PE is manufactured by AZmed.
What is the FDA product code for Rayvolve PTX-PE?
The FDA product code for Rayvolve PTX-PE is QFM.
Other Devices by AZmed
Related Devices (Code: QFM)
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.