DE BAKEY Spring-Loaded Vascular Clamp – Straight, 50 mm

Overview

The DE BAKEY Spring-Loaded Vascular Clamp (Model R32005-50) is a precision-engineered surgical instrument designed for temporary occlusion of blood vessels during open and minimally invasive vascular, cardiothoracic, neurosurgical, and general surgical procedures. Based on the classic DeBakey design principle—characterized by parallel jaw alignment, uniform pressure distribution, and minimal tissue trauma—the clamp utilizes a stainless steel torsion spring mechanism to deliver consistent, repeatable clamping force without manual adjustment. Its straight configuration and 50 mm overall length provide optimal reach and maneuverability in deep or confined anatomical fields, while maintaining ergonomic control for extended procedural use. Constructed from medical-grade austenitic stainless steel (ASTM F138/F136 compliant), the device ensures corrosion resistance, mechanical integrity, and compatibility with standard sterilization protocols including steam autoclaving (134 °C, 3 min), ethylene oxide, and low-temperature hydrogen peroxide plasma.

Key Features

• DeBakey-style parallel-jaw geometry ensures even pressure application across vessel walls, reducing risk of intimal injury or slippage during occlusion.
• Precision-machined torsion spring delivers calibrated, fatigue-resistant clamping force—engineered for ≥1,000 sterilization cycles without loss of spring tension.
• Smooth, non-reflective satin finish minimizes glare under surgical lighting and enhances tactile feedback during handling.
• Distal jaw tips feature micro-textured surfaces (Ra ≤ 0.8 µm) to improve grip on slippery, wet tissues without compromising vessel wall integrity.
• Autoclavable design meets ISO 17664-1 requirements for reprocessing instructions and supports full traceability via laser-engraved model number (R32005-50) and batch identifier on the shank.

Sample Compatibility & Compliance

The R32005-50 clamp is validated for use with human arterial and venous structures ranging from 1.0 mm to 4.5 mm in external diameter, including but not limited to common carotid, femoral, coronary bypass grafts, and cerebral arteries. It complies with ISO 7153-1:2016 (Surgical instruments — Metallic materials — Part 1: Stainless steels) and conforms to the essential requirements of the EU MDR 2017/745 Class I (non-sterile, reusable). All manufacturing processes adhere to ISO 13485:2016 quality management standards. Documentation includes Declaration of Conformity, material certification (EN 10088-1), and biocompatibility test reports per ISO 10993-1 (cytotoxicity, sensitization, intracutaneous reactivity).

Software & Data Management

As a manually operated, non-electronic surgical instrument, the R32005-50 does not incorporate embedded electronics, firmware, or software interfaces. However, its design supports integration into digital perioperative workflows: laser-etched identifiers enable seamless tracking via hospital inventory management systems (e.g., RFID-enabled trays or barcode-scanned logbooks); usage records can be linked to electronic health record (EHR) modules for GLP-aligned procedural documentation; and sterilization cycle data (time, temperature, pressure) may be archived in accordance with FDA 21 CFR Part 11–compliant sterilization management platforms when used in regulated clinical trial settings.

Applications

• Temporary vascular occlusion during carotid endarterectomy and bypass anastomosis.
• Controlled isolation of feeding vessels in tumor resection (e.g., meningioma, AVM).
• Proximal control in peripheral arterial reconstruction and embolectomy.
• Adjunctive use in microvascular free flap surgery for pedicle stabilization prior to anastomosis.
• Training tool in simulation-based surgical curricula for clamping technique validation under laparoscopic and open conditions.

FAQ

Is the R32005-50 clamp supplied sterile?
No. This is a reusable Class I device intended for terminal sterilization by the end-user facility prior to first use.
What is the recommended maximum number of reprocessing cycles?
Validation testing supports ≥1,000 autoclave cycles (134 °C, 3 min, saturated steam) without measurable degradation in spring performance or surface integrity.
Can this clamp be used on pediatric patients?
Yes—its 50 mm length and fine-tuned clamping force are suitable for neonatal and pediatric vasculature when applied under direct visualization and appropriate sizing assessment.
Does RWD provide IFU translations for international markets?
Yes. Multilingual Instructions for Use (English, Spanish, German, French, Japanese, and Simplified Chinese) are available upon request and comply with ISO 15223-1:2021 labeling standards.
Is the device MRI-compatible?
Yes. Constructed entirely from non-ferromagnetic ASTM F138 stainless steel, it poses no projectile risk and induces negligible artifact at 1.5T and 3.0T field strengths.