Type N Endocardial Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K810493 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the Type N Endocardial Lead used for in clinical practice?

  The Type N Endocardial Lead is designed for endocardial placement within the heart’s chambers to deliver electrical stimulation. It is specifically intended for use in cardiac pacing systems to help regulate heart rhythm in patients diagnosed with bradycardia (slow heart rate) or conduction disorders, ensuring proper cardiac function.

• Is the Type N Endocardial Lead intended for reuse or single-use, and how is it supplied?

  The Type N Endocardial Lead is supplied sterile and is intended for single-use implantation only. This ensures patient safety and sterility during the procedure, as it is not designed for reuse.

• What types of MRI compatibility does this lead have, and should I be concerned about using it in an MRI environment?

  The Type N Endocardial Lead is compatible with MRI environments under specified conditions, meaning it can be used in patients who may require MRI scans after implantation. However, the exact MRI safety parameters (e.g., field strength, imaging sequences) should be confirmed with the manufacturer’s guidelines or technical documentation to avoid risks like heating or displacement.

• How do I identify the correct model or reference code for this lead when ordering?

  This lead is available in multiple model numbers and reference codes, including 3002618605, 3008377825, 1028232, and others listed under the registration numbers (e.g., 2017865, 2032521). When ordering, verify the exact model required for your patient’s pacing system, as compatibility with the pacemaker device is critical. The manufacturer’s product catalog or technical specifications should be consulted for precise matching.