Views: 0 Author: BOVA Publish Time: 2026-04-27 Origin: Site
This 14Fr medical introducer sheath semi-finished product is precision extruded from medical-grade PEBAX 7233 resin, completed with three core post-processing techniques: laser scale marking, proximal flared hub forming, and distal bevel cutting. It serves as a critical foundational component for manufacturing interventional, minimally invasive surgical, and drainage medical devices.
As an unsterilized, uncertified industrial-grade semi-finished product, it is exclusively designed for medical device manufacturers with valid production qualifications and certification capabilities. It can be directly used for subsequent assembly, sterilization, and regulatory compliance processes, significantly shortening product development cycles and reducing production costs.
We offer full customization services for all dimensions and processes, allowing adjustments to tube diameter, length, scale style, and tip structure based on your clinical requirements to meet personalized application needs across different surgical scenarios.
Parameter | Detailed Specification |
|---|---|
Nominal Size | 14 French (Fr) |
Corresponding Outer Diameter | ≈4.67mm |
Standard Length | 100mm (10cm; customizable from 50mm to 300mm) |
Wall Thickness | 0.5mm (customizable from 0.3mm to 1.0mm) |
Core Material | Medical-grade PEBAX 7233 (Shore 72D Hardness) |
Post-Processing | UV laser scale marking + proximal flared hub + distal 45° bevel cut |
Scale Accuracy | ±0.1mm |
Surface Roughness | Ra≤0.4μm |
Biocompatibility | Compliant with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Skin Irritation) |
Sterilization Status | Unsterilized (supports subsequent EO/gamma sterilization by customers) |
Certification Status | No FDA/CE/NMPA certification (semi-finished state) |
Packaging | Individually packaged in clean PE bags, with moisture-proof and dust-proof outer cartons |
Medical-grade UV laser etching technology is used to create clear, permanent scales on the tube surface with a depth of 10-20μm. The markings are abrasion-resistant, chemical-resistant, and will never peel off, eliminating clinical risks associated with ink shedding from traditional screen printing. Scales are evenly distributed from 1cm to 10cm, with numerical markings every 1cm and short tick marks every 1mm, enabling accurate insertion depth judgment during surgery and improving procedural accuracy and safety.
The proximal end of the tube is processed into a standard flared hub structure using precision thermal forming technology. The flared edge is smooth without burrs or flash, with a uniform inner diameter transition. This design significantly reduces insertion resistance for guidewires, balloon catheters, and other interventional instruments, prevents instrument jamming or tube deformation, and facilitates quick connection to syringes, negative pressure devices, and other supporting equipment.
The distal end of the tube is cut into a 45° bevel using CNC precision cutting technology, and the tip is polished to a rounded, sharp-free finish. The beveled tip effectively minimizes tissue damage during puncture, reduces patient bleeding and infection risks, and improves sheath deliverability through blood vessels, body cavities, and soft tissues, allowing surgeons to quickly establish surgical access.
PEBAX 7233 is one of the most widely used high-performance thermoplastic elastomers in interventional medical devices, offering unmatched comprehensive performance compared to traditional PVC, TPU, and nylon materials:
Excellent balance of rigidity and flexibility: 72D high hardness ensures sufficient support to maintain lumen patency without collapse, while retaining excellent flexibility to conform to natural body cavity curvatures
Superior kink resistance and fatigue durability: Resists permanent deformation or fracture after repeated bending, ideal for procedures involving complex anatomical structures
Low friction coefficient: Smooth inner and outer surfaces significantly reduce instrument delivery resistance and tissue friction damage
Outstanding biocompatibility: Non-cytotoxic and non-sensitizing, safe for contact with human tissues and blood
Excellent chemical resistance: Tolerates common disinfectants such as alcohol and iodine, and is compatible with most clinical medications
High processability: Supports extrusion, injection molding, thermoforming, and welding, enabling complex structural designs
This 14Fr PEBAX 7233 introducer sheath semi-finished product is widely used in the manufacturing of various minimally invasive interventional surgical instruments, including:
Vascular access sheaths (femoral artery sheaths, radial artery sheaths, venous sheaths)
Non-vascular drainage sheaths (thoracic drainage, abdominal drainage, abscess drainage)
Endoscopic surgical working channel sheaths
Guidewire protectors and instrument protective sleeves
Custom medical catheter prototype development and small-batch trial production
Interventional device R&D for animal experiments
We provide comprehensive medical catheter customization solutions, allowing adjustments to the following parameters based on your requirements:
Dimension customization: Full range of sizes from 8Fr to 24Fr, lengths customizable from 50mm to 1000mm
Process customization: Adjustable scale styles (units, spacing, colors), flare angles and dimensions, and tip shapes (straight cut, bevel cut, rounded tip, tapered tip)
Functional customization: Addition of radiopaque marker bands, multi-lumen structures, side holes, hydrophilic coatings, and antimicrobial coatings
Material customization: Available in full range of PEBAX hardness grades: 3533, 4033, 5533, 6333, and 7033
Subsequent processing: One-stop services including assembly, sterilization, and packaging (available upon separate consultation)
Minimum Order Quantity (MOQ): 1,000 pieces for standard specifications; 5,000 pieces for customized specifications
Lead Time: 7-10 working days for standard specifications; 15-25 working days for customized specifications
Sample Policy: Free standard specification samples available (freight collect); customized samples require a sample fee
Quality Control: All products undergo strict dimensional inspection, visual inspection, pressure testing, and biocompatibility testing
Shipping: Supports domestic express, international air freight, and sea freight; can be selected according to customer needs
Important Disclaimer: This product is a medical semi-finished component, unsterilized and uncertified as a medical device. It is strictly prohibited for direct clinical use on humans. It may only be processed and certified by medical device manufacturers with the appropriate qualifications.