All instruments are reusable and certified according to:
Mega Vessel Dilator for Deepest Maximum Vessel Surgery
The DE BAKEY VESSEL DILATOR FLEXIBLE 4.0MM 19.0 cm is a medical device of CE Class I according to ISO 13485:2016. This flexible mega dilator with maximum length was specifically developed for the gentle dilation of extremely large main vessels in deepest maximum vascular surgery, cardiac surgery and transplantation surgery.
Product Highlights:
✔ Certified according to ISO 13485:2016
✔ CE Marking Class I (Regulation (EU) 2017/745 MDR)
✔ DeBakey Vessel Dilator with 4.0 mm mega diameter
✔ Flexible version for deepest maximum vessel dilation
✔ High-quality Stainless Steel 1.4301 – rust-free and biocompatible
✔ Tested Biocompatibility according to ISO 10993
✔ Mega 4.0 mm tip for extremely large main vessels
✔ Maximum 19.0 cm length for deepest maximum vessel procedures
✔ Sterilizable and reusable
✔ Mega special instrument for deepest most demanding main vessel reconstructions
Benefits of the DeBakey Vessel Dilator:
• Mega Flexibility in Depth: Bendable yet ultra-stable construction for most precise vessel dilation in deepest regions
• Mega Size with Ultra Reach: 4.0 mm ideal for extremely large vessels, aorta, vena cava and deepest main trunk anastomoses
• Atraumatic Mega Deep Tip: High-gloss polished surface minimizes vessel injuries in mega caliber
• Precise Mega Deep Handling: Maximum length for ultimate control in deepest mega vessel procedures
• High-Quality Mega Deep Design: Robust ultra-precision instrument for deepest most demanding procedures
Technical Specifications:
• Model: DE BAKEY VESSEL DILATOR FLEXIBLE
• Total Length: 19.0 cm
• Diameter: 4.0 mm
• Construction: Flexible mega vessel dilator with deep reach
• Tip: Rounded, ultra-atraumatic
• Material: Stainless Steel 1.4301
• Form: Straight, flexible mega shaft
• Surface: High-gloss polished for optimal gliding properties
• Flexibility: Minimal bend for stable mega vessel dilation in depth
• Risk Class: I according to Regulation (EU) 2017/745 MDR
Fields of Application:
• Deepest maximum vascular surgical mega anastomoses
• Cardiac surgical deep mega vessel reconstructions
• Deep transplantation surgery with mega vessels
• Deep aortic surgery and iliac mega reconstructions
• Trauma deep mega vessel repairs
• Deep most complex bypass surgery with main trunks
• Arterial deep mega reconstructions
Important Safety Information:
• FOR USE BY MEGA-SPECIALIZED VASCULAR SURGICAL PROFESSIONALS ONLY
• Apply only under strict aseptic conditions in maximum care centers
• Check for damage and surface integrity before use
• Exercise extreme caution during dilation of extremely large, often atheromatous or calcified vessels in depth
• Not suitable for excessive force application
• Use ultra-controlled deep dilation technique
• Stop dilation immediately if resistance, massive calcifications or plaques are encountered
• Exercise maximum care near deep aneurysmal or dissected mega vascular structures
• Intensive regular inspection of shaft stability and tip integrity with ultra reach required
• Use only after comprehensive imaging diagnostics
• Special caution in patients with deep mega vessel pathologies
• Exercise utmost concentration and attention with maximum reach applications
• Strictly follow reprocessing guidelines for reuse
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All instruments are certified according to:
