FDA-Cleared 15mm Kyphoplasty Balloon Catheter for Vertebral Compression Fractures
Product Summary
Changmei's KB0115 is a single-use, FDA-cleared kyphoplasty balloon catheter designed for minimally invasive treatment of vertebral compression fractures. With a 15mm balloon length and 8G size, it delivers reliable performance for height restoration and kyphosis correction. The device is CE marked, ISO 13485 certified, and sterilized with EO for safety.
Key Features
- FDA 510(k) Cleared: K223709, Class II, cleared August 16, 2023 – U.S. market authorization.
- 15mm Radiopaque Markers: Precise balloon positioning under fluoroscopy.
- High Burst Pressure: ≥400 PSI ensures reliability during inflation.
- Medical-Grade TPU: Biocompatible, stress-crack resistant, four-wing pleating for uniform expansion.
- Sterile Single-Use: EO-sterilized, 3-year shelf life.
Technical Specifications
| Parameter | Value |
|---|
| Model | KB0115 |
| Distance of Two Radiopaque Markers | 15 mm |
| Channel ID | ≥3.65 mm |
| Overall Length | 315 mm |
| Maximum Volume | 4 cc |
| Constrained Burst Pressure | ≥400 PSI |
| Size/Type | 8G |
Models and Options
This 15mm balloon is part of Changmei's 8G PKP catheter family. Options include:
- KB0210 – 10mm balloon
- KB0115 – 15mm balloon (this model)
- KB0120 – 20mm balloon
Materials and Structure
The balloon catheter is made of medical-grade thermoplastic polyurethane (TPU) mounted on a PU shaft, with tantalum radiopaque markers and a stainless-steel stylet. Handle components use polycarbonate. The four-wing pleating structure ensures uniform expansion and smooth deflation for removal.
Applications
Indicated for minimally invasive treatment of painful vertebral compression fractures due to osteoporosis, trauma, or neoplasia. Also used for symptomatic vertebral hemangiomas. Performed in orthopedic spine surgery, interventional radiology, and pain management settings.
Customization
OEM/ODM options available for private labeling, packaging, and sterile configurations. MOQ for standard products: 10 sets. Custom orders: negotiable quantity.
FAQ
Q: Is this balloon catheter FDA approved?
A: Yes, it is cleared under FDA 510(k) K223709, cleared August 16, 2023.
Q: What is the burst pressure rating?
A: The constrained burst pressure is ≥400 PSI, ensuring reliable inflation.
Q: What sizes are available?
A: 10mm (KB0210), 15mm (KB0115), and 20mm (KB0120) are offered.
Q: How is it sterilized?
A: EO sterilization is used, with a 3-year shelf life.
Q: Can I get OEM packaging?
A: Yes, OEM/ODM is available with negotiable MOQ.
Q: What is the MOQ?
A: Standard MOQ is 10 sets.
Inquiry Information
For pricing, lead time, and technical specifications, contact:
Mark
Email: cyz@czmed.com
Tel/WhatsApp: +86 138-1368-7682
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