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dermaport vascular access device model no 50-1000
Thermedics
Summary: The Dermaport Vascular Access Device, model no 50-1000, by Thermedics is used for vascular access, primarily in venous-stent procedures. It is utilized by healthcare professionals in vascular surgery and interventional radiology.
FDA Clearance Information
Pathway
510K
Number
K894131 ↗
Decision Date
September 26, 1989
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Dermaport Vascular Access Device was cleared via the FDA 510k pathway on September 26, 1989. Manufactured by Thermedics, it is classified as a Class 2 device under product code DQY.
What It Is
The Dermaport Vascular Access Device is a specialized medical device designed to facilitate vascular access, particularly in procedures involving venous stents. It provides a reliable and secure entry point into the vascular system, allowing for the insertion of stents or other therapeutic devices. This device is crucial in maintaining vascular patency and ensuring effective treatment delivery.
Clinical Applications
Commonly used in vascular surgery and interventional radiology, this device is essential for procedures requiring venous access, such as the placement of stents in patients with venous obstructions. It is often employed in hospital settings, particularly in operating rooms and catheterization labs. The device is suitable for adult patients who require long-term vascular access for treatment.
Indications for Use
The FDA indications suggest that this device is intended for patients needing vascular access for venous stent placement. It is particularly useful for individuals with conditions that result in narrowed or obstructed veins, requiring intervention to restore proper blood flow.
Practical Considerations
Clinicians should consider the typical sizing of the device to ensure compatibility with the patient's vascular anatomy. It is important to follow proper aseptic techniques during insertion to minimize infection risk. The device is compatible with standard vascular access equipment.
Frequently Asked Questions
What is the Dermaport Vascular Access Device used for?
It is used for providing vascular access, particularly in procedures involving the placement of venous stents.
What specialties typically use this device?
This device is commonly used by vascular surgeons and interventional radiologists.
What are the FDA-cleared indications?
The device is indicated for patients requiring vascular access for venous stent placement, especially in cases of venous obstructions.
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.