Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
FDA 510(k) K251970 · Medtronic, Ireland
510(k) numberK251970
Submission
- Device name
- Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
- Applicant
- Medtronic, Ireland
Galway, IE - Received
- June 26, 2025
- Decision date
- January 17, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LOX – Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5100
- Specialty
- Cardiovascular
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 510(k)s with product code LOX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261428 | NC Euphora Rapid Exchange Balloon Dilatation CatheterLOX · Traditional | Medtronic Ireland | 08/14/2026SE |
| K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation CatheterLOX · Traditional | Medtronic Ireland | 07/27/2026SE |
| K252116 | Firefighter Pro PTCA Balloon CatheterLOX · Traditional | Shanghai MicroPort Medical (Group) Co., Ltd. | 04/07/2026SE |
| K254022 | FLASH Flex Aorto-Ostial Angioplasty SystemLOX · Traditional | Verge Medical, Inc. | 04/02/2026SE |
| K252295 | RyureiLOX · Traditional | Terumo Corporation | 03/27/2026SE |
| K242969 | Pantera Pro; Pantera LEOLOX · Special | Biotronik, Inc. | 10/25/2024SE |
| K233499 | Sapphire NC ULTRA Coronary Dilatation CatheterLOX · Traditional | OrbusNeich Medical (Shenzhen) Co., Ltd. | 08/16/2024SE |
| K233505 | Sapphire ULTRA Coronary Dilatation CatheterLOX · Traditional | OrbusNeich Medical (Shenzhen) Co., Ltd. | 08/15/2024SE |
| K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon…LOX · Traditional | Vascular Solutions, LLC | 05/31/2024SE |
| K223189 | Firefighter NC Pro PTCA Balloon CatheterLOX · Traditional | Shanghai MicroPort Medical (Group) Co., Ltd. | 07/21/2023SE |
More from Shanghai MicroPort Medical (Group) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261428 | NC Euphora Rapid Exchange Balloon Dilatation CatheterLOX · Traditional | 08/14/2026SE |
| K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation CatheterLOX · Traditional | 07/27/2026SE |
| K252390 | Telescope Guide Extension CatheterDQY · Traditional | 10/29/2025SE |
| K250787 | Liberant Thrombectomy SystemQEW · Traditional | 06/11/2025SE |
| K123153 | Attain Command+Surevalve Left Heart Delivery System Attain Command Guide Catheters for…DQY · Traditional | 04/09/2013SE |
| K103095 | Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw BalloonLOX · Traditional | 10/22/2010SE |
| K061480 | Attain 6227DEF Deflectable Catheter Delivery SystemDQY · Traditional | 08/21/2006SE |
| K053431 | Attain Select II 6248DEL Delivery Catheter SystemDQY · Traditional | 03/16/2006SE |
Questions and answers
When was Sprinter Legend Rapid Exchange Balloon Dilatation Catheter cleared by the FDA?
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (K251970) received a 510(k) decision of Substantially Equivalent on January 17, 2026, 205 days after the submission was received.
What is the product code of K251970?
The FDA product code is LOX – Catheters, Transluminal Coronary Angioplasty, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.5100.