Description
Medical devices require components that combine dimensional accuracy, smooth surface quality, and reliable performance. Our PTFE mandrels are designed to provide stable internal support during catheter manufacturing and guidewire assembly, helping improve processing accuracy while protecting delicate device structures.
Manufactured from medical-grade PTFE, every mandrel is produced under an ISO 13485 certified quality management system in an ISO Class 7 (Class 10,000) cleanroom. We offer flexible customization for diameter, wall thickness, length, and tip design to meet the requirements of cardiovascular, neurovascular, and other minimally invasive medical applications.
Key Features
Our PTFE mandrels are engineered to meet the demanding requirements of modern medical device manufacturing.
- Medical-grade PTFE material
- Excellent low-friction, non-stick surface
- High chemical resistance and biocompatibility
- Stable dimensional accuracy
- Excellent flexibility and kink resistance
- Custom diameters and lengths available
- ISO 13485 certified manufacturing
- Produced in an ISO Class 7 cleanroom
- OEM and ODM customization supported
Product Specifications
| Parameter | Specification |
|---|---|
| Material | Medical-grade PTFE |
| Inner Diameter | 0.33–2.32 mm (custom) |
| Outer Diameter | 0.5–6 mm |
| Wall Thickness | Customized |
| Standard Length | 86–218 mm |
| Maximum Length | Up to 300 cm or 200 m/roll |
| Tolerance | Up to ±0.02 mm* |
| Manufacturing | ISO 13485 / ISO Class 7 Cleanroom |
*Depending on product dimensions.
Typical Applications
Our PTFE mandrels are widely used in the manufacture of:
- Balloon catheters
- Neurovascular catheters
- Guidewires
- Microcatheters
- Delivery systems
- Introducer sheaths
- Diagnostic catheters
- Electrophysiology devices
- Peripheral vascular devices
- Other minimally invasive medical instruments
Custom Manufacturing
Every medical project has unique requirements. FOBOS provides customized PTFE mandrels based on customer drawings or technical specifications.
Customization options include:
- Outer diameter (OD)
- Inner diameter (ID)
- Wall thickness
- Length
- Tapered or rounded tips
- Surface finish
- Packaging requirements
Our engineering team works closely with customers from prototype development through volume production to ensure every component meets application requirements.
Quality Manufacturing
Quality consistency is essential for medical components.
Our PTFE mandrels are manufactured using carefully controlled processes that include raw material inspection, precision extrusion, dimensional inspection, cleanroom processing, and final quality verification.
Production is carried out under an ISO 13485 certified quality management system with complete product traceability. Cleanroom manufacturing helps reduce contamination and supports the cleanliness requirements of medical device assembly.
Frequently Asked Questions
Can you manufacture custom dimensions?
Yes. We manufacture according to customer drawings and support customized diameters, wall thicknesses, lengths, and tip geometries.
What industries use PTFE mandrels?
They are commonly used in cardiovascular intervention, neurovascular devices, diagnostic catheters, guidewire manufacturing, and other minimally invasive medical applications.
What quality standards do you follow?
Our production follows an ISO 13485 certified quality management system, and manufacturing is performed in an ISO Class 7 cleanroom environment.
Can you provide samples?
Yes. Samples are available for evaluation before mass production. Please contact us with your specifications.
Contact FOBOS
Looking for a reliable medical PTFE mandrel manufacturer?
Our engineering team is ready to help you develop customized PTFE mandrels for your catheter or guidewire project.
Email: info@fobospolymer.com
WhatsApp / Phone: +86 18914343919
Website: https://fobospolymer.com/contact/
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