DE BAKEY VASCULAR DILATATOR MALLEABLE 3,5MM 35,0CM

DE BAKEY VESSEL DILATOR • 3.5MM • 35.0CM • CE CLASS I • ISO 13485:2016

Flexible Vessel Dilator for Maximum Vessel Dilation

The DE BAKEY VESSEL DILATOR 3.5 mm / 35.0 cm is a medical device of CE Class I according to ISO 13485:2016. This flexible dilator with its large-caliber 3.5 mm tip and flexible construction is specifically designed for maximum dilation and preparation of large-caliber 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 large-caliber 3.5 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
• Large-Caliber Tip: 3.5 mm design for maximum vessel dilation
• Enhanced Stability: Reinforced construction for large-caliber vessels
• Precise Handling: Excellent tactility despite larger tip size
• 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: 3.5 mm
• Construction: Flexible shaft
• Tip: Large-caliber, rounded, atraumatic
• Material: Stainless Steel 1.4301
• Shape: Straight, with flexible distal end
• Surface: High-gloss polished for optimal gliding properties
• Special Feature: Reinforced flexible construction for large-caliber vessels
• Risk Class: I according to Regulation (EU) 2017/745 MDR

Areas of Application:

• Vascular surgical procedures on large-caliber vessels
• Maximum arterial and venous dilation
• Cardiac surgical procedures on major vessels
• Peripheral vessel preparation in large calibers
• Vessel reconstructions of aorta and major veins
• Traumatological vascular access in major trauma

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
• Special caution when dilating venous structures