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FDA 510(k)

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

K-Number: K251970 · 2026-01-17

ApplicantMedtronic, Ireland
Decision Date2026-01-17
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter is a medical device manufactured by Medtronic, Ireland. It received FDA 510(k) clearance on 2026-01-17 under approval number K251970. 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 Sprinter Legend Rapid Exchange Balloon Dilatation Catheter?

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2026-01-17. It is manufactured by Medtronic, Ireland. The 510(k) number is K251970.

When was Sprinter Legend Rapid Exchange Balloon Dilatation Catheter approved by the FDA?

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter received FDA 510(k) clearance on 2026-01-17, under approval number K251970.

What company makes Sprinter Legend Rapid Exchange Balloon Dilatation Catheter?

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter is manufactured by Medtronic, Ireland.

What is the FDA product code for Sprinter Legend Rapid Exchange Balloon Dilatation Catheter?

The FDA product code for Sprinter Legend Rapid Exchange Balloon Dilatation Catheter is LOX.

Related Clinical Trials

NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING NCT06492174 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort ACTIVE_NOT_RECRUITING NCT07214948 Open, Randomized Feasibility Trial on the Safety and Performance of the INGA Catheter for Labor Induction NOT_YET_RECRUITING NCT07414771 Safety and Usability of the Inga Catheter for Labor Induction (INGA-MDP) NOT_YET_RECRUITING NCT07587541 Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter NOT_YET_RECRUITING

Other Devices by Medtronic, Ireland

K252390Telescope Guide Extension Catheter K250787Liberant Thrombectomy System PMA P030009STENT, CORONARY PMA P110011STENT, ILIAC

Related Devices (Code: LOX)

K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation CatheteBoston Scientific Corporation K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation K160985Pantera ProBiotronik, Inc. K162209Sapphire NC PlusOrbusneich Medical, Inc. K153742Apollo Balloon Dilatation CatheterBrosmed Medical Co., Ltd. K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited

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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