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Temp Pervenous Lead W Remote Anode
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 ?
510(k)
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.
FDA-Cleared Indications
- Temporary transvenous cardiac pacing when short-term pacing support is required.
- Use as a temporary pervenous lead with a remote anode in cardiovascular procedures, according to the device labeling.
Clinical Applications
- Temporary transvenous pacing in patients who require short-term cardiac rhythm support.
- Temporary cardiovascular access or lead placement during monitored hospital procedures, when performed according to the product labeling.
Reported off-label uses
- Use as a temporary intracardiac electrode for electrophysiologic testing or rhythm assessment may occur in clinical practice, but this should not be assumed to be an FDA-cleared indication for this specific device.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- Confirm the lead size, connector, length and electrical compatibility with the intended external pulse generator or monitoring system before use.
- Insertion requires venous access and should be performed by clinicians trained in percutaneous vascular access, fluoroscopic or other appropriate imaging, and temporary pacing.
- Potential complications include bleeding, infection, venous injury, arrhythmia, lead displacement, loss of capture and cardiac perforation.
- MRI safety should not be assumed. The lead and all connected components should be evaluated against current manufacturer labeling and the conditions of the planned MRI examination.
- The device is intended for temporary use; duration and removal should follow the product labeling and the patient's clinical needs.
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.