Avantec Vascular Corporation
Medical device company focused on design, development, manufacturing and regulatory support for vascular interventional devices. Maintains ISO 13485-aligned quality systems and cleanroom manufacturing, and conducts prototype development, pre-clinical and clinical support for catheter, guidewire, stent and retrieval device technologies.
Industries
Nr. of Employees
medium (51-250)
Avantec Vascular Corporation
Products
Vascular retrieval system (foreign object retrieval device)
Endovascular retrieval device intended to capture and remove intravascular foreign objects such as guide wires, coils, balloons, catheters and filters using a braided loop/snare mechanism and shapeable shaft.
Vascular retrieval system (foreign object retrieval device)
Endovascular retrieval device intended to capture and remove intravascular foreign objects such as guide wires, coils, balloons, catheters and filters using a braided loop/snare mechanism and shapeable shaft.
Services
Concept-to-prototype R&D services including feasibility studies, prototype fabrication, design reviews, risk analyses and support for pre-clinical/clinical evaluation.
Manufacturing services including transfer of designs to production, process validation, cleanroom assembly and lot release testing under an ISO 13485 quality system.
Regulatory planning and preparation of submissions, quality system implementation, supplier audits and support for sterilization/biocompatibility testing.
Concept-to-prototype R&D services including feasibility studies, prototype fabrication, design reviews, risk analyses and support for pre-clinical/clinical evaluation.
Manufacturing services including transfer of designs to production, process validation, cleanroom assembly and lot release testing under an ISO 13485 quality system.
Regulatory planning and preparation of submissions, quality system implementation, supplier audits and support for sterilization/biocompatibility testing.
Expertise Areas
- Vascular interventional device development
- Design verification and validation
- Medical device manufacturing and process validation
- Quality management systems (ISO 13485, GMP)
Key Technologies
- SolidWorks / CAD
- Catheter and guidewire design
- Vascular retrieval mechanisms
- PEEK and medical-grade polymer shafts
News & Updates
Company states it is ISO 13485 certified and maintains an effective Quality Management System aligned to international standards and regulations.
Company states it is ISO 13485 certified and maintains an effective Quality Management System aligned to international standards and regulations.