Electrode, Pacemaker, Permanent
by Pacesetter Systems 510(k)
Active
510(k) K823033
Overview
This device is a permanent pacemaker electrode, classified under the nomenclature for cardiac pacing systems. It is designed for implantation within the heart to deliver electrical stimulation and regulate abnormal heart rhythms, ensuring consistent cardiac contractions in patients with bradycardia or conduction disorders.
The electrode is intended for surgical implantation by a healthcare professional in a clinical setting. It is supplied sterile and intended for single-use, with regulatory clearance under FDA 510(k) (K823033) as a Class III device under the DTB product code. No additional context regarding sterility, MRI safety, or reusable status is provided in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823033 | Date30 Dec 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DTB
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pacesetter Systems
Questions
What is the primary purpose of this pacemaker electrode, and how is it used in clinical practice?
This permanent pacemaker electrode is designed to regulate abnormal heart rhythms by delivering electrical stimulation directly to the heart. It is surgically implanted by a healthcare professional to ensure consistent cardiac contractions in patients with bradycardia or conduction disorders. The electrode works in conjunction with a pacemaker device to maintain proper heart function.
Is this electrode intended for single-use or can it be reused after implantation?
The electrode is explicitly labeled for single-use only. While the data does not specify reuse restrictions beyond this, standard medical practice for permanent pacemaker electrodes aligns with single-use to ensure sterility and patient safety.
How is this device supplied, and what should clinicians expect when receiving it?
The electrode is supplied sterile, meaning it is packaged and prepared for immediate use in a clinical setting without additional sterilization. Clinicians should expect to receive it pre-sterilized, ready for surgical implantation as part of a permanent pacemaker system.
What regulatory pathway was followed for this device’s clearance, and which committee reviewed it?
This device received FDA clearance through a 510(k) submission, classified as a Class III device under the DTB (Defibrillator, Pacemaker, and Cardiac Resynchronization Therapy) product code. The review was conducted by the Cardiovascular (CV) Advisory Committee, and the decision was made under the Traditional 510(k) Review pathway, with the device deemed Substantially Equivalent to a predicate.