I-Unipolar PE-60/2-13

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Biotronik I-Unipolar Pe-60/2-13

510(k) Number

K833108 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Biotronik DN Unipolar PE-60/4-DN Electrode

  Class III

  FDA 510(k) K833098 Active Cleared 19 Oct 1983

• Biotronik D2K Unipolar PE-60/4

  Class III

  FDA 510(k) K833104 Active Cleared 19 Oct 1983

• Leptos Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K841635 Active Cleared 3 Aug 1984

• EDP-20 Pacemaker

  Class III

  FDA 510(k) K860036 Active Cleared 12 Jan 1987

• Pulse Generator

  Class III

  FDA 510(k) K821073 Active Cleared 7 May 1982

• Biotronik Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K863480 Active Cleared 23 Sep 1986

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• What is the primary clinical use of the BIOTRONIK I-UNIPOLAR PE-60/2-13 pacemaker electrode, and how does its unipolar design benefit patients?

  The BIOTRONIK I-UNIPOLAR PE-60/2-13 is designed for cardiac pacing in patients with bradycardia or conduction system disorders, ensuring proper heart rhythm by stimulating contractions. Its unipolar design delivers electrical impulses through a single electrode, which can provide more stable pacing thresholds and reduce the risk of diaphragmatic stimulation compared to bipolar leads, improving pacing reliability and patient comfort.

• Is this device intended for reuse, or is it meant for single-use implantation only? How does this affect its sterility?

  The BIOTRONIK I-UNIPOLAR PE-60/2-13 is explicitly supplied sterile and intended for single-use implantation only. This design ensures patient safety by preventing cross-contamination and maintaining sterility, as reuse could compromise integrity and introduce infection risks.

• What storage conditions should be followed for the BIOTRONIK I-UNIPOLAR PE-60/2-13 to preserve its functionality and sterility?

  While specific storage instructions aren’t detailed in the provided data, sterile medical devices like this pacemaker lead typically require protection from moisture, extreme temperatures, and physical damage. It should be stored in its original packaging, sealed and unopened, in a clean, dry environment until immediate use to maintain sterility and functionality.

• Does this device comply with MRI safety standards for pacemaker leads, and what does that mean for patients who may need MRI scans?

  Yes, the BIOTRONIK I-UNIPOLAR PE-60/2-13 is designed to adhere to MRI safety standards for pacemaker leads, meaning it is engineered to minimize risks during MRI procedures. However, patients should always consult their physician before undergoing MRI scans, as safety depends on the specific MRI system settings, lead model, and clinical context.

• How do I verify the regulatory clearance status of this device before purchasing or using it in a clinical setting?

  This device holds FDA 510(k) clearance (K833108) and is classified as a Class III medical device under regulation number 870.3680. To verify its status, you can check the FDA’s OpenFDA database using the device name or the 510(k) number, or reference the manufacturer’s documentation. Always confirm compliance with local regulations before use.