Siemens Elema Models 4025 and 4026 Adapters
by Pacesetter Systems 510(k)
Active
510(k) K890547
Overview
The Siemens Elema Models 4025 and 4026 Adapters are classified as Permanent Pacemaker Electrodes, designed as connectors or interfaces for use with implantable pacemaker systems. These adapters facilitate electrical connectivity between the pacemaker generator and the electrode lead, ensuring proper signal transmission for cardiac pacing.
These adapters are intended for use in cardiovascular procedures within a sterile environment, supplied as reusable medical devices. They are regulated under FDA 510(k) clearance (K890547) and fall under product code DTB, classified as Class III devices. No specific MRI safety or single-use designation is noted in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK890547 | Date22 Mar 1989 | 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- Withdrawn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 the Siemens Elema Models 4025 and 4026 Adapters in a pacemaker system?
These adapters serve as connectors or interfaces between the implantable pacemaker generator and the electrode lead. Their role is to ensure reliable electrical connectivity, enabling proper signal transmission for cardiac pacing during cardiovascular procedures.
Are the Siemens Elema Models 4025 and 4026 Adapters designed for single-use or reusable applications?
The adapters are explicitly labeled as reusable medical devices, meaning they are intended for repeated use in sterile environments after proper cleaning and maintenance.
What regulatory pathway was followed for FDA clearance of these adapters, and what classification do they hold?
The Siemens Elema Models 4025 and 4026 Adapters were cleared through a traditional 510(k) pathway and are classified as Class III devices under FDA regulations, with product code DTB.
What types of procedures or settings are these adapters intended for?
These adapters are designed for use in cardiovascular procedures, specifically within sterile environments where implantable pacemaker systems are deployed, such as operating rooms or electrophysiology labs.
Are there any specific notes about MRI compatibility or restrictions for these adapters?
The available data does not mention any specific MRI safety designation for the Siemens Elema Models 4025 and 4026 Adapters, so their use in MRI environments should be carefully evaluated or avoided unless confirmed safe by the manufacturer.