Permanent Endocardial Unipolar Tined/Wedge Electrode

No FDA recalls on record, checked 22 Oct 2026.

Full name

Perm. Endocardial Unipolar Tined/Wedge

510(k) Number

K802552 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Adapter Kit

  Class II

  FDA 510(k) K781864 Active Cleared 19 Dec 1978

• Pacemaker, Perm. & Temp., Electrode

  Class III

  FDA 510(k) K772197 Active Cleared 30 Jan 1978

• Permanent Lead Intraducer

  Class II

  FDA 510(k) K800356 Active Cleared 28 May 1980

• Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K800352 Active Cleared 28 May 1980

• Daig Pacel(Tm) Flow Directed Pacing Catheter

  Class II

  FDA 510(k) K890794 Active Cleared 20 Jun 1989

• Unipolar Lead Configuration Conductor

  Class III

  FDA 510(k) K800348 Active Cleared 28 May 1980

See all devices from Daig Corp. →

• What types of patients is this device intended for, and how does it work in their treatment?

  This device is designed for patients with chronic bradycardia or conduction disorders requiring long-term pacing therapy. The unipolar endocardial electrode delivers electrical stimulation directly to the heart muscle, ensuring stable positioning within the cardiac chamber through its tined or wedge fixation mechanism. This stable placement facilitates reliable pacing over extended periods, supporting chronic cardiac rhythm management.

• Is this device reusable, and if not, how should it be handled to maintain sterility before use?

  This device is intended for single-use only and is supplied sterile. To maintain sterility, it must be handled using aseptic techniques as instructed by the manufacturer. Avoid opening the sterile packaging until immediately before implantation, and ensure the device is not exposed to contamination or environmental exposure that could compromise its sterility.

• What storage conditions are required to preserve the device’s functionality and sterility?

  The device must be stored according to the manufacturer’s instructions to maintain both sterility and functionality. Typically, this includes keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Check the packaging for specific storage guidelines, such as refrigeration or room-temperature storage, to ensure optimal performance.

• Can this device be used in patients who require MRI scans, and if so, are there any restrictions?

  Yes, this device is compatible with MRI environments under specific conditions. However, the exact parameters (e.g., MRI machine type, field strength, and imaging sequences) must be followed as outlined in the manufacturer’s instructions to avoid risks such as heating or displacement of the electrode. Always verify compatibility with your MRI facility’s protocols before use.

• How do I identify the correct model or reference code for this device, and why does it matter?

  This device is available in multiple model numbers and reference codes, as listed in the FDA registration records (e.g., FEI numbers like 3002618605 or registration numbers like 2017865). The correct model matters because it ensures compatibility with your pacemaker system, proper sizing for the patient’s anatomy, and adherence to manufacturer specifications for implantation and use. Always confirm the model matches your clinical needs and the device’s intended use.