510(k) K103095

SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON by Medtronic, Ireland — Product Code LOX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 22, 2010
Date Received: October 8, 2010
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class: Class II
Regulation Number: 870.5100
Review Panel: CV
Submission Type

A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

Other clearances by Medtronic, Ireland

K251970 — Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (January 17, 2026)
K252390 — Telescope Guide Extension Catheter (October 29, 2025)
K250787 — Liberant Thrombectomy System (June 11, 2025)
K123153 — ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETE (April 9, 2013)
K061480 — ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM (August 21, 2006)
K053431 — ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM (March 16, 2006)

Other clearances for product code LOX

K251970 — Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (January 17, 2026)
K242969 — Pantera Pro; Pantera LEO (October 25, 2024)
K233499 — Sapphire NC ULTRA Coronary Dilatation Catheter (August 16, 2024)
K233505 — Sapphire ULTRA Coronary Dilatation Catheter (August 15, 2024)
K233729 — Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon (May 31, 2024)
K223189 — Firefighter NC Pro PTCA Balloon Catheter (July 21, 2023)
K230374 — Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Ballo (June 29, 2023)
K230705 — POT PTCA Balloon Dilatation Catheter (April 11, 2023)
K223022 — SC HONKYTONK PTCA Balloon Dilatation Catheter (February 15, 2023)
K222538 — NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter (December 21, 2022)