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polystan wire reinforced catheters and cannulae
Polystan C/O Vitalcor
Summary: The Polystan wire reinforced catheters and cannulae are medical devices used primarily in vascular procedures to provide support and facilitate fluid transfer. They are commonly used by vascular surgeons and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K872182 ↗
Decision Date
October 30, 1987
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Polystan wire reinforced catheters and cannulae were cleared through the FDA 510(k) pathway on October 30, 1987. Manufactured by Polystan C/O Vitalcor, this device is classified as Class 2 under product code DQY.
What It Is
The Polystan wire reinforced catheters and cannulae are designed to provide structural support and flexibility during vascular procedures. These devices are reinforced with wire to enhance durability and kink resistance, making them suitable for navigating complex vascular pathways. They are typically used in procedures requiring reliable fluid transfer or drainage.
Clinical Applications
These catheters and cannulae are commonly used in vascular surgery and interventional radiology, particularly in procedures involving venous access or stenting. They are suitable for use in hospital settings, including operating rooms and catheterization labs. The devices are often employed in adult and pediatric patient populations requiring vascular interventions.
Indications for Use
The FDA indications suggest that these devices are intended for use in procedures requiring venous access or support, such as the placement of venous stents. They are suitable for patients needing enhanced vascular access or drainage.
Practical Considerations
These devices come in various sizes to accommodate different patient anatomies and procedural requirements. They are compatible with standard vascular access equipment and require careful handling to avoid damage to the wire reinforcement. Clinicians should be familiar with the specific insertion techniques to ensure optimal performance.
Frequently Asked Questions
What is Polystan wire reinforced catheters and cannulae used for?
They are used for providing structural support and facilitating fluid transfer in vascular procedures.
What specialties typically use this device?
Vascular surgeons and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
They are indicated for use in procedures requiring venous access or support, such as venous stenting.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.