Pantera Pro; Pantera LEO
FDA 510(k) K242969 · Biotronik, Inc.
510(k) numberK242969
Submission
- Device name
- Pantera Pro; Pantera LEO
- Applicant
- Biotronik, Inc.
Lake Oswego, OR, US - Received
- September 26, 2024
- Decision date
- October 25, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
|---|---|---|
| K261074 | Biomonitor IV (471155)MXD · Special | 05/01/2026SE |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special | 04/04/2025SE |
| K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool…DQY · Traditional | 09/12/2024SE |
| K241711 | Oscar Peripheral Multifunctional Catheter systemLIT · Special | 07/11/2024SE |
| K230375 | Biomonitor IVMXD · Traditional | 05/19/2023SE |
| K222065 | Passeo-35 Xeo Peripheral Dilatation CatheterLIT · Traditional | 02/16/2023SE |
| K221856 | BIOMONITOR IIIm, BIOMONITOR IIIMXD · Special | 07/27/2022SE |
| K222037 | Selectra Lead Implantation SystemDQY · Special | 07/19/2022SE |
| K214038 | Oscar Peripheral Multifunctional Catheter systemLIT · Traditional | 07/06/2022SE |
| K201445 | MultiCath, AcQRate Dx Fixed Curve CatheterDRF · Traditional | 09/02/2021SE |
Questions and answers
When was Pantera Pro; Pantera LEO cleared by the FDA?
Pantera Pro; Pantera LEO (K242969) received a 510(k) decision of Substantially Equivalent on October 25, 2024, 29 days after the submission was received.
What is the product code of K242969?
The FDA product code is LOX – Catheters, Transluminal Coronary Angioplasty, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.5100.