Data / Medical devices / Ireland / Perfuze

Perfuze: FDA-registered device maker in Dangan Galway(County), Ireland, 11 510(k) clearances

Name: Perfuze FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Perfuze is registered with the FDA (registration 3015701715) in Dangan Galway(County), Ireland. It lists 2 device types. The FDA files 11 510(k) clearances under its listings, the newest dated August 12, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015701715
Address: Unit 6 Galway Business Park, Dangan Galway(County), Ireland, H91 W7CP
Owner or operator: Perfuze (10086972)
Roles: Manufacturer
First device listed: December 28, 2022
Registered through: 2026
Brand names listed: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set, Millipede 088 Access Catheter, Millipede System, Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set, Millipede88 Access Catheter, Zipline Access Catheter

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Percutaneous, Neurovasculature	QJP	2	Manufacturer	accessdata.fda.gov
Catheter, Thrombus Retriever	NRY	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 12, 2026	K262399	Millipede System	NRY	Substantially Equivalent	Perfuze, Ltd.	accessdata.fda.gov
July 9, 2026	K253901	Millipede88 Access Catheter	QJP	Substantially Equivalent	Perfuze, Ltd.	accessdata.fda.gov
March 16, 2026	K253590	Millipede System	NRY	Substantially Equivalent	Perfuze, Ltd.	accessdata.fda.gov
August 29, 2025	K252392	Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set	NRY	Substantially Equivalent	Perfuze, Ltd.	accessdata.fda.gov
February 26, 2025	K250012	Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set	NRY	Substantially Equivalent	Perfuze, Ltd.	accessdata.fda.gov
October 17, 2024	K240711	Zipline Access Catheter	QJP	Substantially Equivalent	Perfuze, Ltd.	accessdata.fda.gov
September 20, 2024	K242504	Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set	NRY	Substantially Equivalent	Perfuze, Ltd.	accessdata.fda.gov
December 14, 2023	K233648	Millipede 088 Access Catheter	QJP	Substantially Equivalent	Perfuze, Ltd.	accessdata.fda.gov
October 18, 2023	K232524	Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set	NRY	Substantially Equivalent	Perfuze, Ltd.	accessdata.fda.gov
September 19, 2023	K231802	Millipede 088 Access Catheter	QJP	Substantially Equivalent	Perfuze, Ltd.	accessdata.fda.gov
September 20, 2022	K214048	Millipede 088 Access Catheter	QJP	Substantially Equivalent	Perfuze, Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.