Euphora Rapid Exchange (RX) Balloon Dilatation Catheter— 510(k) K261759
Substantially EquivalentMedtronic Ireland
FDA 510(k) clearance K261759 for Euphora Rapid Exchange (RX) Balloon Dilatation Catheter, Substantially Equivalent on 2026-07-27. Applicant: Medtronic Ireland. Device class: 2.
Clearance details
- Applicant
- Medtronic Ireland
- Product code
- Code LOX
- Device class
- Class 2
- Regulation
- 21 CFR 870.5100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Galway, IE
Recent devices under product code LOX
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- K123153 — ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT
- K103095 — SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
- K061480 — ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
Adverse events under product code LOX
product code LOX- Death
- 190
- Injury
- 1,498
- Malfunction
- 9,670
- Total
- 11,358
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.