Euphora Rapid Exchange Balloon Dilatation Catheter— 510(k) K143480

Name: FDA 510(k) clearance K143480
Creator: U.S. Food and Drug Administration
Published: 2015-04-02

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K143480 for Euphora Rapid Exchange Balloon Dilatation Catheter, Substantially Equivalent on 2015-04-02. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code LOX
Device class: Class 2
Regulation: 21 CFR 870.5100
Advisory panel: Cardiovascular
Date received: 2014-12-08
Decision date: 2015-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code LOX

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K261428 — NC Euphora Rapid Exchange Balloon Dilatation Catheter2026-08-14
K261759 — Euphora Rapid Exchange (RX) Balloon Dilatation Catheter2026-07-27
K252116 — Firefighter Pro PTCA Balloon Catheter2026-04-07
K254022 — FLASH Flex Aorto-Ostial Angioplasty System2026-04-02
K252295 — Ryurei2026-03-27

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K261866 — Concerto Versa Detachable Coil2026-06-24
K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23

Adverse events under product code LOX

product code LOX

Death: 190
Injury: 1,498
Malfunction: 9,670
Total: 11,358

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 →

Recalls naming K143480

K-number listed on FDA's recall record

Z-0122-2020 — Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, EUP3025X, EUP3030X, EUP32506X, EUP32510X, EUP32512X, EUP32515X, EUP32520X, EUP32525X, EUP3506X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP3525X, EUP3530X, EUP37506X, EUP37510X, EUP37512X, EUP37515X, EUP37520X, EUP37525X, EUP4006X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030XClass II·Ongoing·Medtronic Vascular Galway DBA Medtronic Ireland·20190903
Z-3136-2017 — Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.Class II·Terminated·Medtronic Vascular Galway DBA Medtronic Ireland·20170713
Z-3137-2017 — Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.Class II·Terminated·Medtronic Vascular Galway DBA Medtronic Ireland·20170713

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143480.

Data sourced from openFDA. This site is unofficial and independent of the FDA.