Ryurei
FDA 510(k) K252295 · Terumo Corporation
510(k) numberK252295
Submission
- Device name
- Ryurei
- Applicant
- Terumo Corporation
Tokyo, JP - Received
- July 23, 2025
- Decision date
- March 27, 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 |
| 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 |
| 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 |
|---|---|---|
| K250700 | Pen Injector Needle 32.5FMI · Traditional | 11/21/2025SE |
| K250751 | DualView CatheterDQO · Traditional | 07/17/2025SE |
| K240818 | R2P Radifocus Glidewire AdvantageDQX · Traditional | 11/26/2024SE |
| K240859 | Glidewire GT-RDQX · Traditional | 08/21/2024SE |
| K190427 | ImmuciseFMF · Traditional | 07/18/2019SE |
| K181369 | Immucise Intradermal Injection SystemFMI · Traditional | 11/13/2018SE |
| K173799 | NaviCross 0.018DQY · Traditional | 03/29/2018SE |
| K170417 | Glidewire GTDQX · Traditional | 09/15/2017SE |
| K130493 | Capiox RX05 Hollow Fiber Oxygenator/ReservoirDTZ · Special | 03/13/2013SE |
| K130280 | Capiox FX Hollow Fiber Oxygenator W/ ReservoirDTZ · Special | 03/13/2013SE |
Questions and answers
When was Ryurei cleared by the FDA?
Ryurei (K252295) received a 510(k) decision of Substantially Equivalent on March 27, 2026, 247 days after the submission was received.
What is the product code of K252295?
The FDA product code is LOX – Catheters, Transluminal Coronary Angioplasty, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.5100.