đź“‹ FDA Reference
vs-1 lead ext 033-302 4 75mm 033-260 033-458
Telectronics Pacing Systems
Summary: The vs-1 lead ext 033-302 is a lead extension device used in cardiac pacing systems. It is primarily utilized by cardiologists in procedures requiring lead extensions for pacemakers or defibrillators.
FDA Clearance Information
Pathway
510K
Number
K901402 ↗
Decision Date
June 12, 1990
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The vs-1 lead ext 033-302, manufactured by Telectronics Pacing Systems, was cleared by the FDA via the 510k pathway on June 12, 1990. It is classified as a Class III medical device under product code DTB.
What It Is
The vs-1 lead ext 033-302 is a lead extension device designed for use in conjunction with cardiac pacing systems, such as pacemakers and implantable cardioverter-defibrillators (ICDs). It serves to extend the reach of the leads that connect these devices to the heart, ensuring proper placement and functionality. This device is crucial in cases where the standard lead length is insufficient due to patient anatomy or specific procedural requirements.
Clinical Applications
This lead extension is commonly used in cardiology, particularly in electrophysiology labs and during cardiac surgery. It is indicated for patients requiring pacemaker or ICD implantation where the standard lead length is inadequate. Typical patient populations include those with complex cardiac anatomy or those undergoing revision procedures where additional lead length is necessary.
Indications for Use
The FDA indications suggest this device is used for patients needing extended lead lengths in cardiac pacing systems. It is suitable for individuals undergoing pacemaker or ICD implantation when standard leads do not suffice.
Practical Considerations
When using the vs-1 lead ext 033-302, consider the compatibility with existing pacing system components. Ensure proper sizing to match the required extension length, typically around 75mm. Familiarity with lead handling and implantation techniques is essential for optimal outcomes.
Frequently Asked Questions
What is vs-1 lead ext 033-302 used for?
It is used to extend the leads in cardiac pacing systems, such as pacemakers or ICDs, when standard lead lengths are insufficient.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in extending leads in cardiac pacing systems for patients requiring additional lead length.
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.