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FDA 510(k)

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

K-Number: K250012 · 2025-02-26

ApplicantPerfuze, Ltd.
Decision Date2025-02-26
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set is the device name listed in this FDA 510(k) record. The listed applicant is Perfuze, Ltd.. It received FDA 510(k) clearance on 2025-02-26 under 510(k) number K250012. 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 070 Aspiration Catheter; Perfuze Aspiration Tube Set?

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set is a medical device that received FDA 510(k) clearance on 2025-02-26. The listed applicant is Perfuze, Ltd.. The 510(k) number is K250012.

When did Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set receive FDA 510(k) clearance?

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set received FDA 510(k) clearance on 2025-02-26, under 510(k) number K250012.

Who is the listed applicant for Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set?

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 070 Aspiration Catheter; Perfuze Aspiration Tube Set?

The FDA product code for Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set 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) StudyCOMPLETEDNCT05427929Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode DistanceACTIVE_NOT_RECRUITINGNCT06615713CLinical Evaluation of Aspiration for Removal ANd ClearancE of StonesCOMPLETEDNCT07698119A Trial of the Arctx Cool Catheter in Acute PancreatitisNOT_YET_RECRUITING

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.

K262399Millipede SystemK253901Millipede88 Access CatheterK253590Millipede SystemK252392Millipede70 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.K262399Millipede SystemPerfuze, Ltd.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 Limited

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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