Millipede88 Access Catheter— 510(k) K253901

Name: FDA 510(k) clearance K253901
Creator: U.S. Food and Drug Administration
Published: 2026-07-09

Substantially Equivalent

Perfuze, Ltd.

FDA 510(k) clearance K253901 for Millipede88 Access Catheter, Substantially Equivalent on 2026-07-09. Applicant: Perfuze, Ltd.. Device class: 2.

Clearance details

Applicant: Perfuze, Ltd.
Product code: Code QJP
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2025-12-05
Decision date: 2026-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

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More clearances from Perfuze, Ltd.

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K262399 — Millipede System2026-08-12
K253590 — Millipede System2026-03-16
K252392 — Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set2025-08-29
K250012 — Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set2025-02-26
K240711 — Zipline Access Catheter2024-10-17

Adverse events under product code QJP

product code QJP

Death: 43
Injury: 233
Malfunction: 1,010
Total: 1,286

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.