DE BAKEY VASCULAR DILATATOR MALLEABLE 4,0MM 35,0CM

DE BAKEY VESSEL DILATOR • 4.0MM • 35.0CM • CE CLASS I • ISO 13485:2016

Flexible Maximum Dilator for Large-Caliber Vessel Dilation

The DE BAKEY VESSEL DILATOR 4.0 mm / 35.0 cm is a medical device of CE Class I according to ISO 13485:2016. This flexible maximum dilator with its large-volume 4.0 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-volume 4.0 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
• Maximum Tip Strength: 4.0 mm design for large-caliber vessel dilation
• Enhanced Stability: Robust construction for highest dilation forces
• Precise Handling: Optimized tactility for controlled maximum 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 Maximum
• Total Length: 35.0 cm
• Tip Diameter: 4.0 mm
• Construction: Flexible shaft
• Tip: Large-volume, 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 maximum dilation
• 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
• Aortic and vascular reconstructions
• Vessel preparation in major vascular trauma
• Bypass surgery and vessel replacement

Special Safety Notes:
• FOR USE BY EXPERIENCED SURGICAL PERSONNEL ONLY
• Apply only under strict aseptic conditions
• Special caution with atherosclerotic or fragile vessels
• Atraumatic handling to avoid vessel rupture
• 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 and aged vessels