NC Euphora Rapid Exchange Balloon Dilatation Catheter— 510(k) K261428
Substantially EquivalentMedtronic Ireland
FDA 510(k) clearance K261428 for NC Euphora Rapid Exchange Balloon Dilatation Catheter, Substantially Equivalent on 2026-08-14. Applicant: Medtronic Ireland. Device class: 2.
Summary
Medtronic Ireland filed the NC Euphora Rapid Exchange Balloon Dilatation Catheter under product code LOX, percutaneous transluminal coronary angioplasty catheters. No sizes or model numbers are listed.
Class II, 21 CFR 870.5100. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Medtronic filed from Galway, Ireland. FDA found it substantially equivalent 106 calendar days after receipt (April 30 to August 14, 2026).
Clearance details
- Applicant
- Medtronic Ireland
- Product code
- Product 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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view all- K252390 — Telescope Guide Extension Catheter
- K250787 — Liberant Thrombectomy System
- 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.