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FDA 510(k)

Millipede System

K-Number: K262399 · 2026-08-12

ApplicantPerfuze, Ltd.
Decision Date2026-08-12
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Millipede System is the device name listed in this FDA 510(k) record. The listed applicant is Perfuze, Ltd.. It received FDA 510(k) clearance on 2026-08-12 under 510(k) number K262399. 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 2026-08-12. The listed applicant is Perfuze, Ltd.. The 510(k) number is K262399.

When did Millipede System receive FDA 510(k) clearance?

Millipede System received FDA 510(k) clearance on 2026-08-12, under 510(k) number K262399.

Who is the listed applicant for Millipede System?

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

What is the FDA product code for Millipede System?

The FDA product code for Millipede System is NRY.

Related Clinical Trials

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.

NCT05714501Millipede AspiRation for Revascularization in Stroke (MARRS) StudyCOMPLETED

Other records listing Perfuze, Ltd. 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.

K253901Millipede88 Access CatheterK253590Millipede SystemK252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetK250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetK240711Zipline Access CatheterK242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

View all 11 devices →

Related Devices (Code: NRY)

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.

K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech LimitedK254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc.

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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