Biotronik DFH Unipolar PE-60/4-DFH

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

510(k) Number

K833106 ↗

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

See all devices from Biotronik Sales, Inc. →

• Is this pacemaker electrode designed for reuse in multiple patients, or is it intended for single-use only?

  The Biotronik DFH Unipolar PE-60/4-DFH is explicitly intended for single-use implantation only. The device is supplied sterile, which aligns with single-use medical devices meant to be implanted in a single patient to avoid contamination risks. Reuse is not supported or documented in the provided specifications.

• What types of storage conditions are recommended for this device before implantation?

  Since the device is supplied sterile and intended for single-use, it should be stored in its original packaging under controlled conditions to maintain sterility. While exact storage details (e.g., temperature, humidity) aren’t specified, standard sterile medical device storage practices—such as keeping it in a clean, dry environment away from direct sunlight—are advised. Always follow manufacturer instructions if additional guidance is provided.

• Can this electrode be used with any pacemaker system, or is it compatible only with specific Biotronik devices?

  The Biotronik DFH Unipolar PE-60/4-DFH is designed as a permanent pacemaker electrode for use in Biotronik’s pacing systems, but compatibility specifics (e.g., pacemaker models) aren’t detailed in the provided data. Clinicians should verify compatibility with their chosen pacemaker system by consulting Biotronik’s technical documentation or support resources, as electrode-pacemaker pairing is critical for safe and effective cardiac rhythm management.

• How do I know if this device is the correct size for my patient’s anatomy?

  The model name PE-60/4-DFH includes a 60 cm length designation, which is a key sizing parameter for pacemaker leads. The ‘4’ may refer to the electrode’s design (e.g., tines or fixation mechanism), but exact anatomical fit depends on the patient’s venous anatomy and implantation site. Clinicians should measure the patient’s venous pathway pre-procedure and confirm the lead’s length and fixation type align with their needs, as improper sizing can affect pacing performance or lead stability.

• What should I consider when handling this device to ensure sterility is maintained during implantation?

  The device is supplied sterile, so it must be handled using aseptic techniques throughout the procedure. This includes keeping the packaging intact until immediate use, avoiding contamination (e.g., touching the electrode with gloved hands), and adhering to sterile field protocols during implantation. Since it’s single-use, any breach of sterility—such as improper packaging handling—would invalidate the device for use, requiring replacement with a new sterile unit.