Millipede System— 510(k) K253590
Substantially EquivalentPerfuze, Ltd.
FDA 510(k) clearance K253590 for Millipede System, Substantially Equivalent on 2026-03-16. Applicant: Perfuze, Ltd.. Device class: 2.
Summary
Perfuze's Millipede System is filed under NRY, thrombus retriever catheters. The record doesn't list catheter sizes or components.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Perfuze filed from Galway, Ireland. The decision came 119 calendar days after FDA received it (November 17, 2025 to March 16, 2026).
Clearance details
- Applicant
- Perfuze, Ltd.
- Product code
- Product code NRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Galway, IE
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More clearances from Perfuze, Ltd.
view allAdverse events under product code NRY
product code NRY- Death
- 411
- Injury
- 1,712
- Malfunction
- 1,855
- Total
- 3,978
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.