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temp pervenous lead w remote anode
Cordis
Summary: The temp pervenous lead with remote anode by Cordis is a Class III medical device used primarily in cardiovascular procedures. It is utilized by cardiologists and interventional radiologists for specific vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K770214 ↗
Decision Date
March 28, 1977
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on March 28, 1977. Manufactured by Cordis, it is classified as a Class III device under product code DTB.
What It Is
The temp pervenous lead with remote anode is a specialized medical device designed for temporary vascular access. It consists of a lead that is inserted pervenously and is used in conjunction with a remote anode to facilitate certain cardiovascular procedures. This device is critical in managing complex vascular conditions and is typically used in a hospital setting.
Clinical Applications
Commonly used in interventional cardiology and radiology, this device is employed in procedures requiring temporary vascular access, such as the placement of IVC filters. It is particularly useful in managing patients with thromboembolic disorders or those requiring temporary pacing. The device is used in both adult and pediatric populations, often in critical care or surgical settings.
Indications for Use
The FDA indications suggest this device is intended for patients requiring temporary vascular interventions, such as those with thromboembolic conditions. It is suitable for use in procedures where temporary pacing or vascular access is necessary.
Practical Considerations
Clinicians should be aware of the sizing and compatibility with existing vascular systems. The technique for insertion requires familiarity with pervenous access, and proper training is essential to ensure successful deployment and patient safety.
Frequently Asked Questions
What is temp pervenous lead w remote anode used for?
It is used for temporary vascular access in cardiovascular procedures, such as the placement of IVC filters or temporary pacing.
What specialties typically use this device?
This device is typically used by cardiologists and interventional radiologists.
What are the FDA-cleared indications?
The device is indicated for patients needing temporary vascular interventions, particularly in managing thromboembolic conditions.
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.