DE BAKEY VASCULAR DILATATOR MALLEABLE 3,0MM 35,0CM

DE BAKEY VESSEL DILATOR • 3.0MM • 35.0CM • CE CLASS I • ISO 13485:2016

Flexible Vessel Dilator for Atraumatic Dilation of Larger Vessels

The DE BAKEY VESSEL DILATOR 3.0 mm / 35.0 cm is a medical device of CE Class I according to ISO 13485:2016. This flexible dilator with its robust 3.0 mm tip and flexible construction is specifically designed for the gentle dilation and preparation of larger vessels in demanding vascular and cardiac surgery.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I (Regulation (EU) 2017/745 MDR)
✔ Flexible shaft for anatomical adaptability
✔ DeBakey design with robust 3.0 mm atraumatic tip
✔ High-quality stainless steel 1.4301 – rust-free and biocompatible
✔ Tested biocompatibility according to ISO 10993
✔ Atraumatic grooves for safe tissue handling
✔ Maximum 35.0 cm length for deep surgical access
✔ Sterilizable and reusable

Advantages of the Vessel Dilator:

• Flexible Construction: Allows adaptation to vessel anatomy for safe procedures
• Robust Tip: 3.0 mm design for larger vessels and enhanced stability
• Optimized Flexibility: Ideal balance between flexibility and rigidity
• Precise Handling: Excellent tactility for controlled dilation
• Optimal Reach: 35.0 cm for deep thoracic and abdominal procedures
• Proven Design: Classic DeBakey concept for reliable performance

Technical Specifications:

• Model: DE BAKEY VESSEL DILATOR Flex
• Total Length: 35.0 cm
• Tip Diameter: 3.0 mm
• Construction: Flexible shaft
• Tip: Robust, rounded, atraumatic
• Material: Stainless Steel 1.4301
• Shape: Straight, with flexible distal end
• Surface: High-gloss polished for optimal gliding properties
• Special Feature: High-quality flexible construction for anatomical work
• Risk Class: I according to Regulation (EU) 2017/745 MDR

Areas of Application:

• Vascular surgical procedures on larger vessels
• Arterial and venous dilation
• Cardiac surgical procedures
• Peripheral vessel preparation
• Vessel reconstructions
• Traumatological vascular access

Special Safety Notes:
• FOR USE BY EXPERIENCED SURGICAL PERSONNEL ONLY
• Apply only under strict aseptic conditions
• Special caution with atherosclerotic vessels
• Atraumatic handling to avoid vascular injuries
• Check integrity and functionality before use
• Controlled, graduated dilation technique required
• Special care near vulnerable vessel sections
• Strictly adhere to reprocessing guidelines for reuse
• Do not bend flexible shaft beyond physiological radius