Identifiers
- 510(k) Number
- K023205 FDA 510(k)
- FDA Product Code
- DTB FDA 510(k)
- Models / Variants
- Elox P 45-Bp FDA 510(k)Elox P 53-Bp FDA 510(k)Elox P 60-Bp 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
- ST FDA 510(k)
The Elox P 45-BP, Elox P 53-BP, and Elox P 60-BP are permanent pacemaker electrodes designed for implantation in the cardiovascular system. These devices are intended for use as leads in pacemaker systems to deliver electrical stimulation to the heart, facilitating proper cardiac rhythm regulation in patients with bradycardia or other conduction disorders.
These leads are supplied sterile and intended for single-use implantation. They are available in three distinct lengths—45 cm, 53 cm, and 60 cm—to accommodate varying patient anatomies. The devices are classified under FDA product code DTB and have received FDA 510(k) clearance as substantially equivalent with subject-to-tracking regulatory status, ensuring compliance with Class III medical device requirements.
Frequently asked questions
Are these pacemaker electrodes reusable or designed for single-use only, and how does that affect their sterility?
The Elox P leads (45-BP, 53-BP, and 60-BP) are explicitly supplied sterile and intended for single-use implantation only. This design ensures patient safety by eliminating the risk of contamination from reuse, which is critical in cardiovascular procedures where infection control is paramount.
What are the key differences between the Elox P 45-BP, 53-BP, and 60-BP models, and how do I choose the right length for a patient?
The three models differ solely by lead length: 45 cm, 53 cm, and 60 cm. The choice depends on the patient’s anatomy and the implantation site. Shorter leads (e.g., 45 cm) may suit smaller patients or specific access routes, while longer leads (e.g., 60 cm) accommodate taller patients or complex anatomies requiring deeper placement. Always verify the patient’s measurements pre-procedure.
How should these leads be stored before use, and are there any special handling requirements?
While the data doesn’t specify storage conditions, as sterile single-use devices, they should be stored in their original packaging in a clean, dry environment protected from moisture, extreme temperatures, or direct sunlight. Avoid exposure to contaminants or physical damage that could compromise sterility or integrity before implantation.
What regulatory pathway was followed for these leads, and what does the ‘subject-to-tracking’ status mean for clinicians?
The Elox P leads received FDA 510(k) clearance under the Traditional Review pathway, classified as Class III devices (product code DTB). The ‘subject-to-tracking’ status means Biotronik must monitor post-market performance to ensure ongoing safety and effectiveness, though it doesn’t alter the device’s approved use or clinical indications. Clinicians should confirm compliance with tracking requirements if reporting adverse events.
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. Sources consulted: ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (K023205) — FDA 510 (k ..., ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP - fda.report, Elox P 45-bp; Elox P 53-bp; Elox P 60-bp - Beudamed, elox p 45-bp elox p 53-bp elox p 60-bp - lavascular.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023205 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K023205 24 fields · synced Sep 18, 2026