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FDA 510(k)

Euphora Rapid Exchange (RX) Balloon Dilatation Catheter

K-Number: K261759 · 2026-07-27

ApplicantMedtronic Ireland
Decision Date2026-07-27
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Euphora Rapid Exchange (RX) Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Ireland. It received FDA 510(k) clearance on 2026-07-27 under 510(k) number K261759. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Euphora Rapid Exchange (RX) Balloon Dilatation Catheter?

Euphora Rapid Exchange (RX) Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2026-07-27. The listed applicant is Medtronic Ireland. The 510(k) number is K261759.

When did Euphora Rapid Exchange (RX) Balloon Dilatation Catheter receive FDA 510(k) clearance?

Euphora Rapid Exchange (RX) Balloon Dilatation Catheter received FDA 510(k) clearance on 2026-07-27, under 510(k) number K261759.

Who is the listed applicant for Euphora Rapid Exchange (RX) Balloon Dilatation Catheter?

The FDA 510(k) record lists Medtronic Ireland as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Euphora Rapid Exchange (RX) Balloon Dilatation Catheter?

The FDA product code for Euphora Rapid Exchange (RX) Balloon Dilatation Catheter is LOX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03472118High Flow Oxygen in Patients Undergoing Suspension Laryngoscopy Under General AnesthesiaTERMINATEDNCT05509296Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery DiseaseCOMPLETEDNCT06832631VITUS Post-Market RegistryACTIVE_NOT_RECRUITINGNCT07397390an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified LesionsENROLLING_BY_INVITATION

Other records listing Medtronic Ireland as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterK252390Telescope Guide Extension CatheterK250787Liberant Thrombectomy SystemPMA P030009STENT, CORONARYPMA P110011STENT, ILIAC

Related Devices (Code: LOX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.K252295RyureiTerumo CorporationK251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, IrelandK242969Pantera Pro; Pantera LEOBiotronik, Inc.K233499Sapphire NC ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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