JADE PLUS PTA Balloon Dilatation Catheter
FDA 510(k) K241025 · OrbusNeich Medical (Shenzhen) Co., Ltd.
510(k) numberK241025
Submission
- Device name
- JADE PLUS PTA Balloon Dilatation Catheter
- Applicant
- OrbusNeich Medical (Shenzhen) Co., Ltd.
Shenzhen, CN - Received
- April 15, 2024
- Decision date
- June 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIT – Catheter, Angioplasty, Peripheral, Transluminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Other 510(k)s with product code LIT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260304 | WAVE PTA Balloon CatheterLIT · Traditional | WAVE Medical AG | 05/20/2026SE |
| K252512 | Armada 14 NC PTA CatheterLIT · Traditional | Abbott Medical | 02/13/2026SE |
| K251915 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | Natec Medical , Ltd. | 12/18/2025SE |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special | Biotronik, Inc. | 04/04/2025SE |
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…LIT · Traditional | Brosmed Medical Co., Ltd. | 02/27/2025SE |
| K241040 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | Natec Medical , Ltd. | 12/18/2024SE |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT · Traditional | Creagh Medical Ltd. Dba Surmodics, Inc. | 11/15/2024SE |
| K241740 | Finesse Injectable PTA Balloon Dilatation CatheterLIT · Special | Summa Therapeutics | 07/16/2024SE |
| K241711 | Oscar Peripheral Multifunctional Catheter systemLIT · Special | Biotronik, Inc. | 07/11/2024SE |
| K241683 | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling…LIT · Special | Boston Scientific Corporation | 07/10/2024SE |
More from Boston Scientific Corporation
| 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 |
| K233505 | Sapphire ULTRA Coronary Dilatation CatheterLOX · Traditional | 08/15/2024SE |
| 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 JADE PLUS PTA Balloon Dilatation Catheter cleared by the FDA?
JADE PLUS PTA Balloon Dilatation Catheter (K241025) received a 510(k) decision of Substantially Equivalent on June 11, 2024, 57 days after the submission was received.
What is the product code of K241025?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.