Sapphire ULTRA Coronary Dilatation Catheter
FDA 510(k) K233505 · OrbusNeich Medical (Shenzhen) Co., Ltd.
510(k) numberK233505
Submission
- Device name
- Sapphire ULTRA Coronary Dilatation Catheter
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
Shenzhen, CN - Received
- October 31, 2023
- Decision date
- August 15, 2024
- 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 |
| 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 |
| 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 |
|---|---|---|
| K253361 | Teleport Glide MicrocatheterDQY · Traditional | 04/10/2026SE |
| K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)DQY · Traditional | 01/07/2025SE |
| K233499 | Sapphire NC ULTRA Coronary Dilatation CatheterLOX · Traditional | 08/16/2024SE |
| K241025 | JADE PLUS PTA Balloon Dilatation CatheterLIT · Traditional | 06/11/2024SE |
| K231608 | Teleport XT MicrocatheterDQY · Traditional | 01/07/2024SE |
| K211807 | Sapphire NC 24LOX · Traditional | 10/14/2021SE |
| K202231 | JadeLIT · Traditional | 12/10/2020SE |
| K201794 | JadeLIT · Special | 07/28/2020SE |
Questions and answers
When was Sapphire ULTRA Coronary Dilatation Catheter cleared by the FDA?
Sapphire ULTRA Coronary Dilatation Catheter (K233505) received a 510(k) decision of Substantially Equivalent on August 15, 2024, 289 days after the submission was received.
What is the product code of K233505?
The FDA product code is LOX – Catheters, Transluminal Coronary Angioplasty, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.5100.