DE BAKEY VASCULAR DILATATOR MALLEABLE 4,5MM 19,0CM

DE BAKEY VESSEL DILATOR FLEXIBLE 4.5MM • 19.0 CM • CE CLASS I • ISO 13485:2016

Ultra Mega Vessel Dilator for Deepest Special Vessel Surgery

The DE BAKEY VESSEL DILATOR FLEXIBLE 4.5MM 19.0 cm is a medical device of CE Class I according to ISO 13485:2016. This flexible ultra mega dilator with maximum length was specifically developed for the gentle dilation of most extremely large main vessels in deepest special vascular surgery, cardiac surgery and transplantation surgery ultra procedures.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE Marking Class I (Regulation (EU) 2017/745 MDR)
✔ DeBakey Vessel Dilator with 4.5 mm ultra mega diameter
✔ Flexible version for deepest ultra maximum vessel dilation
✔ High-quality Stainless Steel 1.4301 – rust-free and biocompatible
✔ Tested Biocompatibility according to ISO 10993
✔ Ultra mega size 4.5 mm tip for most extremely large main vessels
✔ Maximum 19.0 cm length for deepest ultra special procedures
✔ Sterilizable and reusable
✔ Ultra mega special instrument for deepest most demanding special vessel reconstructions

Benefits of the DeBakey Vessel Dilator:

• Ultra Mega Flexibility in Depth: Bendable yet hyper-stable construction for ultra-precise vessel dilation in deepest regions
• Ultra Mega Size with Maximum Reach: 4.5 mm ideal for most extremely large vessels, infrarenal aorta, vena cava and deepest special trunk anastomoses
• Atraumatic Ultra Mega Deep Tip: High-gloss polished surface minimizes vessel injuries in ultra mega caliber
• Precise Ultra Mega Deep Handling: Maximum length for ultra-safe control in deepest special vessel procedures
• High-Quality Ultra Mega Deep Design: Robust hyper-precision instrument for deepest most demanding special procedures

Technical Specifications:

• Model: DE BAKEY VESSEL DILATOR FLEXIBLE
• Total Length: 19.0 cm
• Diameter: 4.5 mm
• Construction: Flexible ultra mega vessel dilator with deep reach
• Tip: Rounded, ultra-atraumatic
• Material: Stainless Steel 1.4301
• Form: Straight, flexible ultra mega shaft
• Surface: High-gloss polished for optimal gliding properties
• Flexibility: Minimal bend for stable ultra mega vessel dilation in depth
• Risk Class: I according to Regulation (EU) 2017/745 MDR

Fields of Application:

• Deepest special vascular surgical ultra mega anastomoses
• Cardiac surgical deep ultra special vessel reconstructions
• Deep transplantation surgery with ultra mega vessels
• Deep aortic surgery of special infrarenal segments
• Trauma deep ultra mega vessel repairs
• Deep most ultra complex bypass surgery with special trunks
• Arterial deep ultra mega reconstructions

Important Safety Information:

• FOR USE BY ULTRA MEGA-SPECIALIZED VASCULAR SURGICAL PROFESSIONALS ONLY
• Apply only under strict aseptic conditions in ultra special centers
• Check for damage and surface integrity before use
• Exercise extreme caution during dilation of most extremely large, pathologically altered vessels in depth
• Not suitable for excessive force application
• Use hyper-controlled deep dilation technique
• Stop dilation immediately if resistance, most massive calcifications or unstable plaques are encountered
• Exercise maximum care near deep aneurysmal, dissected or rupture-prone ultra mega vascular structures
• Intensive regular inspection of shaft stability and tip integrity with maximum reach required
• Use only after most comprehensive imaging diagnostics
• Special caution in patients with deep ultra mega vessel pathologies
• Exercise absolute concentration and attention with maximum reach applications
• Strictly follow reprocessing guidelines for reuse