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amplatz heparin coated catheter
Cook
Summary: The Amplatz heparin coated catheter, manufactured by Cook, is primarily used for reducing thrombogenicity in vascular procedures. Key evidence suggests it is effective in minimizing clot formation compared to non-coated devices.
FDA Clearance Information
Pathway
510K
Number
K832178 ↗
Decision Date
August 12, 1983
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Amplatz heparin coated catheter was cleared by the FDA via the 510(k) pathway on August 12, 1983. It is manufactured by Cook and classified as a Class 2 device under product code DQY.
What It Is
The Amplatz heparin coated catheter is a medical device designed to reduce thrombogenicity during vascular procedures. It is coated with heparin to minimize clot formation, making it suitable for use in venous stents and other vascular interventions.
Clinical Applications
This catheter is commonly used in procedures requiring reduced thrombogenicity, such as the placement of venous stents or other vascular interventions where clot formation is a concern. It is particularly useful in patients with a higher risk of thrombosis.
Evidence Summary
The available literature includes three studies published between 1974 and 1990. These studies focus on the thrombogenicity of heparin-coated devices, with comparisons to non-coated alternatives.
Reported Outcomes
Published studies report that the Amplatz heparin coated catheter significantly reduces clot formation compared to non-coated devices. One study demonstrated less thrombogenicity in hydrophilically coated catheters, while another highlighted its effectiveness in facilitating Hickman catheter placement.
Safety Profile
Reported complications include a reduction in surgical complication rates due to the hypothrombogenic properties of the catheter coating. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the age of the data, with the most recent study published in 1990. Further research is needed to confirm long-term safety and efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Amplatz heparin coated catheter?
The catheter is indicated for use in procedures requiring reduced thrombogenicity, such as venous stent placements and other vascular interventions.
What outcomes have been reported in clinical studies?
Studies report reduced clot formation and lower thrombogenicity compared to non-coated devices, facilitating safer vascular procedures.
What complications have been reported?
Reported complications include a reduction in surgical complication rates due to the catheter's hypothrombogenic coating, with no specific adverse events detailed.
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.