Pacemaker, Perm. & Temp., Electrode

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K772197 ↗

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

• 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

• Response(Tm) Steerable Catheter

  Class II

  FDA 510(k) K913940 Active Cleared 26 Jan 1993

See all devices from Daig Corp. →

• Is this pacemaker electrode designed for single-use or can it be reused in multiple patients?

  This pacemaker electrode is intended for reusable use in clinical settings like cardiac catheterization labs or operating rooms. It is classified as a reusable medical component, meaning it is meant to be sterilized and reused after proper cleaning and processing between patients, rather than being discarded after a single use.

• What types of heart conditions is this electrode intended to address, and how does it work?

  This electrode is designed for both permanent and temporary cardiac pacing to address bradycardia (slow heart rate) or conduction system disorders, where the heart’s natural electrical signals are impaired. It delivers controlled electrical impulses directly to the heart muscle (myocardium) to regulate rhythm and ensure proper cardiac function.

• How should this electrode be handled during use, and what sterility precautions are required?

  Since this electrode is reusable, it must be handled under sterile conditions during each use. While it is not a single-use device, it requires proper sterilization between procedures to prevent infection. Clinicians should follow established protocols for cleaning, disinfection, and sterilization to maintain safety and compliance with medical device regulations.

• What regulatory pathway was followed for FDA clearance, and what does that mean for its safety?

  This device received FDA 510(k) clearance (K772197) under the traditional review pathway, with a decision date of January 30, 1978. The clearance was based on a determination of substantial equivalence to a predicate device, meaning it was found to have the same intended use and technological characteristics as a previously approved device. Compliance with FDA regulation 870.3680 further ensures its safety and performance for cardiovascular applications.

• Are there multiple sizes or models available for this electrode, and how would a clinician determine the correct fit?

  While the provided data does not specify exact sizes or model variations, the device is listed under OpenFDA registration numbers (e.g., 3002618605, 1028232) which may correspond to different electrode configurations or lead types. Clinicians should consult manufacturer documentation or product catalogs to select the appropriate size, length, or fixation mechanism based on patient anatomy, pacing requirements, and procedural needs (e.g., temporary vs. permanent implantation).