ELC 35-UP Model Number 116015 and ELC 54-UP Model Number 115606
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K965106 FDA 510(k)
- FDA Product Code
- DTB FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3680 FDA 510(k)
- Regulation Number
- 870.3680 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- PT FDA 510(k)
This device is a Permanent Pacemaker Electrode, designed for implantation in the cardiovascular system to regulate heart rhythm by delivering electrical impulses. It is intended for use in patients requiring cardiac pacing to treat bradycardia or other conduction disorders, ensuring consistent and reliable cardiac function.
The ELC 35-Up (Model 116015) and ELC 54-Up (Model 115606) are single-use, non-sterile devices supplied in sterile packaging for clinical use. They are classified as Class III medical devices under FDA regulations (870.3680) and were granted 510(k) clearance through a traditional review process by the Cardiovascular Advisory Committee. Storage and handling must comply with manufacturer instructions to maintain device integrity.
Frequently asked questions
Are these pacemaker electrodes designed for single-use or can they be reused after sterilization?
These electrodes (ELC 35-Up Model 116015 and ELC 54-Up Model 115606) are explicitly labeled as single-use devices. While they are supplied in sterile packaging for clinical use, they are not intended for reuse or reprocessing. Reuse could compromise sterility and device integrity, so strict adherence to single-use guidelines is required.
What are the key differences between the ELC 35-Up (Model 116015) and the ELC 54-Up (Model 115606) in terms of clinical application?
The models differ primarily by their electrode configuration—the ELC 35-Up (116015) and ELC 54-Up (115606) are both permanent pacemaker electrodes, but their specific lead designs (e.g., coil or ring electrode count) may influence pacing thresholds and compatibility with certain pacemaker systems. The exact clinical implications depend on the patient’s anatomy and pacing needs, but both are intended for bradycardia or conduction disorder treatment via consistent electrical impulse delivery.
How should these devices be stored to ensure they remain intact and functional before use?
The manufacturer specifies that storage and handling must comply with their instructions to maintain device integrity. Since they are non-sterile but supplied in sterile packaging, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The sterile barrier must remain uncompromised until immediate clinical use to prevent contamination.
What regulatory pathway was followed for FDA clearance of these pacemaker electrodes?
These devices (ELC 35-Up and ELC 54-Up) received FDA 510(k) clearance through a traditional review process by the Cardiovascular Advisory Committee (CV). The submission was classified under product code DTB and was determined to be substantially equivalent to a predicate device, subject to tracking and a Postmarket Surveillance (PMS) requirement. The clearance date was January 27, 1998.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K965106 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K965106 24 fields · synced Sep 18, 2026