Millipede System— 510(k) K262399
Substantially EquivalentPerfuze, Ltd.
FDA 510(k) clearance K262399 for Millipede System, Substantially Equivalent on 2026-08-12. Applicant: Perfuze, Ltd.. Device class: 2.
Clearance details
- Applicant
- Perfuze, Ltd.
- Product code
- Code NRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Galway, IE
Recent devices under product code NRY
view all- K260617 — Tigertriever 13 Ultra Revascularization Device
- K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set
- K262391 — APRO 35 Swift Catheter and Alembic Aspiration Tubing
- K260002 — Socrates Aspiration System (Socrates 70 Aspiration Catheter)
- K250690 — Penumbra System (Thunderbolt Aspiration Tubing)
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.