JADE Plus PTA Balloon Dilatation Catheter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241025 FDA 510(k)
- FDA Product Code
- LIT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The JADE Plus PTA Balloon Dilatation Catheter is a catheter, angioplasty, peripheral, transluminal, designed for the dilation of stenotic or occluded blood vessels in peripheral arteries. It employs a balloon mechanism to mechanically widen narrowed lumens, restoring blood flow and improving vascular patency in peripheral arterial disease (PAD) or similar conditions requiring interventional radiology or vascular surgery.
This catheter is supplied as a single-use, non-sterile device (unless terminally sterilised per manufacturer specifications) and is intended for use in interventional radiology or catheterization laboratories. It is classified as a Class II medical device under FDA regulations (870.1250) and has received FDA 510K clearance, MDD, and MDR authorisations. Available in multiple sizes and reference codes, it must be stored according to manufacturer instructions to maintain integrity and performance, with compatibility confirmed for non-MRI environments.
Frequently asked questions
What is the JADE Plus PTA Balloon Dilatation Catheter primarily used for in clinical practice?
The JADE Plus PTA Balloon Dilatation Catheter is designed for mechanically widening narrowed or blocked blood vessels in peripheral arteries, improving blood flow for patients with peripheral arterial disease (PAD) or similar conditions. It is intended for use in interventional radiology or catheterization labs to restore vascular patency via balloon angioplasty.
Is the JADE Plus PTA Balloon Dilatation Catheter single-use or reusable, and how should it be handled?
The JADE Plus PTA Balloon Dilatation Catheter is supplied as a single-use device. While the manufacturer specifies it is *non-sterile by default*, it may be terminally sterilized—always follow the manufacturer’s instructions for sterilization status and handling to ensure safety and performance. Discard after one use to prevent contamination or degradation.
What storage conditions are required to maintain the integrity of the JADE Plus PTA Balloon Dilatation Catheter?
The catheter must be stored according to the manufacturer’s instructions to preserve its integrity and functionality. Since it is intended for use in non-MRI environments, avoid exposure to magnetic fields. Keep it in a clean, dry place, protected from physical damage, and adhere to expiration dates or shelf-life guidelines provided by OrbusNeich Medical.
How many sizes or reference codes are available for the JADE Plus PTA Balloon Dilatation Catheter, and how can I identify the correct one for my patient?
The JADE Plus PTA Balloon Dilatation Catheter comes in multiple sizes, each corresponding to a unique reference code (e.g., 3011471056, 3011142981, etc.). The correct size depends on the vessel diameter and clinical indication—consult the manufacturer’s sizing guide or catheter selection tools to match the patient’s anatomy. Always verify compatibility with the intended procedure before use.
What regulatory pathways has the JADE Plus PTA Balloon Dilatation Catheter undergone, and how does this affect its availability?
The device has received FDA 510K clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) authorizations, confirming its compliance with global and U.S. standards. This means it is legally marketable in jurisdictions adhering to these regulations, though final availability depends on local healthcare provider procurement policies and institutional approvals. Always verify regional compliance before ordering.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K241025 | Class II | Active |
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Manufacturer
- Manufacturer
- OrbusNeich Medical (Shenzhen) Co., Ltd.
Sources (2)
- FDA 510(k) K241025 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026