LOX
- Product code
- LOX
- Device name
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.5100
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 88
FDA classification definition
A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261428 | 2026-08-14 | Medtronic Ireland | NC Euphora Rapid Exchange Balloon Dilatation Cathete | |
| K261759 | 2026-07-27 | Medtronic Ireland | Euphora Rapid Exchange (RX) Balloon Dilatation Cathe | |
| K252116 | 2026-04-07 | Shanghai MicroPort Medical (Group) Co. | Firefighter Pro PTCA Balloon Catheter | |
| K254022 | 2026-04-02 | Verge Medical, Inc. | FLASH Flex Aorto-Ostial Angioplasty System | |
| K252295 | 2026-03-27 | Terumo Corporation | Ryurei | |
| K251970 | 2026-01-17 | Medtronic, Ireland | Sprinter Legend Rapid Exchange Balloon Dilatation Ca | |
| K242969 | 2024-10-25 | Biotronik, Inc. | Pantera Pro; Pantera LEO | |
| K233499 | 2024-08-16 | OrbusNeich Medical (Shenzhen) Co., Ltd | Sapphire NC ULTRA Coronary Dilatation Catheter | |
| K233505 | 2024-08-15 | OrbusNeich Medical (Shenzhen) Co., Ltd | Sapphire ULTRA Coronary Dilatation Catheter | |
| K233729 | 2024-05-31 | Vascular Solutions, LLC | Ringer perfusion balloon catheter, 2.00 x 20mm (5881 |
Official FDA classification page: LOX
Classification and pathway per current FDA publications. Data from openFDA (CC0).