Model 430-07 Endocardial Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K954610 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

PT

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• What types of pacemakers is the Model 430-07 Endocardial Pacing Lead designed to be used with, and why is this important for clinicians?

  The Model 430-07 is designed for single-use implantation with implantable pulse generators (IPGs), which are the devices that deliver electrical impulses to regulate heart rhythm. This is important because the lead’s passive-fixation, bipolar design and polyurethane insulation sheath ensure stable endocardial stimulation for chronic pacing. Since it’s sterile and intended for one-time use, clinicians must pair it with compatible IPGs to avoid contamination or displacement risks, especially given its reduced diameter, which aids in easier placement.

• Is this lead reusable, or is it meant for one-time use? How does this affect inventory and clinical workflow?

  The Model 430-07 is intended for single-use only, as explicitly stated in its description. This means each lead is sterile upon packaging and should not be reused, reducing infection risks. Clinically, this simplifies workflow by eliminating the need for reprocessing or sterilization, but it does require hospitals to maintain adequate stock levels to avoid shortages during procedures. The lead’s passive-fixation design also supports reliable placement, minimizing the need for replacements due to displacement.

• What are the key features of the Model 430-07 that make it easier to implant compared to other endocardial pacing leads?

  The lead’s reduced diameter is the primary feature that simplifies implantation, as it allows for easier placement through the venous system while minimizing trauma to surrounding tissues. Additionally, its polyurethane insulation sheath and individually coated conductor coils enhance durability and precision during chronic pacing. These design choices help reduce complications like displacement or lead failure, which is critical for long-term reliability in patients requiring permanent pacing.

• How should the Model 430-07 be stored before use, and what precautions should clinicians take to maintain its integrity?

  While the device data does not specify exact storage conditions, as a sterile, single-use lead, it should be stored in its original packaging until immediately before use to preserve sterility. Clinicians should avoid exposing it to moisture, extreme temperatures, or physical damage, as these could compromise the polyurethane sheath or conductor integrity. Since it’s intended for transvenous implantation, ensuring the lead remains uncontaminated and undamaged is essential for safe and effective use.