Millipede88 Access Catheter— 510(k) K253901
Substantially EquivalentPerfuze, Ltd.
FDA 510(k) clearance K253901 for Millipede88 Access Catheter, Substantially Equivalent on 2026-07-09. Applicant: Perfuze, Ltd.. Device class: 2.
Summary
Perfuze's Millipede88 Access Catheter is filed under QJP, neurovasculature percutaneous catheters. The record doesn't give lengths or diameters.
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. Review took 216 calendar days (December 5, 2025 to July 9, 2026).
Clearance details
- Applicant
- Perfuze, Ltd.
- Product code
- Product code QJP
- 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
Recent devices under product code QJP
view allMore clearances from Perfuze, Ltd.
view allAdverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
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.