Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon
FDA 510(k) K103095 · Medtronic, Ireland
510(k) numberK103095
Submission
- Device name
- Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon
- Applicant
- Medtronic, Ireland
Santa Rosa, CA, US - Received
- October 8, 2010
- Decision date
- October 22, 2010
- 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.
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|---|---|---|---|
| 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 |
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| K252295 | RyureiLOX · Traditional | Terumo Corporation | 03/27/2026SE |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation CatheterLOX · Traditional | Medtronic, Ireland | 01/17/2026SE |
| 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 |
More from Vascular Solutions, LLC
| 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 |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation CatheterLOX · Traditional | 01/17/2026SE |
| 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 |
| 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 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon cleared by the FDA?
Sprinter Legend 1.25MM RX and Sprinter Legend 1.25MM Otw Balloon (K103095) received a 510(k) decision of Substantially Equivalent on October 22, 2010, 14 days after the submission was received.
What is the product code of K103095?
The FDA product code is LOX – Catheters, Transluminal Coronary Angioplasty, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.5100.