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FDA 510(k)

Millipede System

K-Number: K253590 · 2026-03-16

ApplicantPerfuze, Ltd.
Decision Date2026-03-16
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Millipede System is a medical device manufactured by Perfuze, Ltd.. It received FDA 510(k) clearance on 2026-03-16 under approval number K253590. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Millipede System?

Millipede System is a medical device that received FDA 510(k) clearance on 2026-03-16. It is manufactured by Perfuze, Ltd.. The 510(k) number is K253590.

When was Millipede System approved by the FDA?

Millipede System received FDA 510(k) clearance on 2026-03-16, under approval number K253590.

What company makes Millipede System?

Millipede System is manufactured by Perfuze, Ltd..

What is the FDA product code for Millipede System?

The FDA product code for Millipede System is NRY.

Related Clinical Trials

NCT04147884 A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation ACTIVE_NOT_RECRUITING

Other Devices by Perfuze, Ltd.

K214048Millipede 088 Access Catheter K233648Millipede 088 Access Catheter K232524Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set K231802Millipede 088 Access Catheter K240711Zipline Access Catheter K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

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Related Devices (Code: NRY)

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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.

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