Electrode Pacemaker, Perm & Temp
by Vitatron Medical BV 510(k)
Active
510(k) K840668
Overview
This device is a Permanent Pacemaker Electrode, a class III medical device designed to facilitate cardiac pacing by delivering electrical impulses to the heart. It is intended for both permanent and temporary implantation to regulate abnormal heart rhythms, ensuring proper cardiac function in patients with bradycardia or conduction disorders.
The Electrode Pacemaker is supplied sterile and intended for single-use or reusable applications, depending on the model. It is regulated under FDA 510(k) clearance (K840668) and falls under the Permanent Pacemaker Electrode nomenclature, adhering to regulatory standards for cardiovascular devices. Models are available in various reference codes, and MRI safety considerations must be evaluated per manufacturer instructions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840668 | Date24 Sep 1984 | 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- Withdrawn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 Vitatron Medical BV
Questions
What types of heart conditions is this electrode pacemaker designed to address, and how does it work?
This electrode pacemaker is specifically designed to manage abnormal heart rhythms by delivering electrical impulses to the heart. It is intended for patients with bradycardia (slow heart rate) or conduction disorders, ensuring proper cardiac function by regulating the heartbeat through permanent or temporary implantation. The device facilitates pacing by stimulating the heart muscle electrically, helping maintain a consistent and effective rhythm.
Is this device single-use or reusable, and how should it be handled to maintain sterility?
This electrode pacemaker is available in both single-use and reusable models, depending on the specific variant. Sterility is maintained as the device is supplied sterile, so single-use models should be used only once and discarded afterward. For reusable models, follow the manufacturer’s instructions for cleaning, sterilization, and reprocessing to ensure safety and functionality before reuse.
What considerations should be taken into account when using this device in a clinical setting, particularly regarding MRI safety?
MRI safety must be carefully evaluated before use, as the electrode pacemaker may interact with magnetic fields. Always refer to the manufacturer’s instructions for specific MRI safety guidelines, as compatibility can vary depending on the model and clinical context. This ensures patient safety during imaging procedures.
How do I determine which model or reference code is appropriate for my patient’s needs?
The appropriate model depends on clinical requirements such as implantation type (permanent or temporary) and patient-specific factors like heart anatomy or pacing needs. The device is available in multiple reference codes, so consult the manufacturer’s documentation or a medical specialist to select the correct model based on your patient’s condition and procedural requirements.