Liberant Thrombectomy System— 510(k) K250787
Substantially EquivalentMedtronic, Ireland
FDA 510(k) clearance K250787 for Liberant Thrombectomy System, Substantially Equivalent on 2025-06-11. Applicant: Medtronic, Ireland. Device class: 2.
Clearance details
- Applicant
- Medtronic, Ireland
- Product code
- Code QEW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Galway, IE
Recent devices under product code QEW
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view all- K261428 — NC Euphora Rapid Exchange Balloon Dilatation Catheter
- K261759 — Euphora Rapid Exchange (RX) Balloon Dilatation Catheter
- K251970 — Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
- K252390 — Telescope Guide Extension Catheter
- K123153 — ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT
Adverse events under product code QEW
product code QEW- Death
- 126
- Injury
- 282
- Malfunction
- 820
- Total
- 1,228
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.