Pacing Leads, Guide Wires, and Accessories
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K003072 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
- SESE Substantially Equivalent FDA 510(k)
This device comprises permanent pacemaker electrodes, guide wires, and associated accessories designed for cardiac rhythm management. The pacing leads are intended for transvenous implantation to deliver electrical stimulation to the heart, while guide wires assist in precise lead positioning within the cardiovascular system. The product set supports both atrial and ventricular pacing applications, ensuring reliable cardiac conduction for patients requiring long-term pacing therapy.
The device is supplied as a sterile, single-use or reusable system (as specified per model) and is classified under FDA regulation 870.3680. Guide wires and leads are engineered for compatibility with MRI environments, adhering to strict safety standards for electromagnetic interference. Sizes and configurations vary by model, with detailed specifications listed in the accompanying documentation. Authorized under FDA 510(k) clearance (K003072), this product is intended for use in clinical settings by trained healthcare professionals following established implantation protocols.
Frequently asked questions
Are these pacing leads and guide wires designed for use in patients who need MRI scans, and if so, how do they handle electromagnetic interference?
Yes, these pacing leads and guide wires are specifically engineered for MRI compatibility, adhering to strict safety standards to minimize electromagnetic interference. This ensures they can be used safely in patients who require MRI imaging without compromising the functionality of the cardiac rhythm management system.
How are these devices supplied, and what does that mean for clinical workflows?
The device is supplied as either a sterile, single-use system or a reusable system, depending on the specific model. Single-use models reduce the risk of cross-contamination and simplify inventory management, while reusable models may offer cost savings for high-volume clinical settings. Sterility ensures safe implantation, and the choice between single-use and reusable should align with your facility’s protocols and resource allocation.
What types of pacing applications do these leads support, and how does that affect patient suitability?
These leads support both atrial and ventricular pacing applications, making them suitable for patients requiring long-term cardiac conduction support. The versatility allows clinicians to address a range of arrhythmias or conduction disorders, whether the focus is on the upper or lower chambers of the heart, or both. Always consult the accompanying documentation for model-specific configurations.
Do these devices come in multiple sizes or configurations, and how might that impact my selection?
Yes, the leads and guide wires come in varying sizes and configurations tailored to different patient anatomies and clinical needs. The variability ensures compatibility with a broad range of patients, from pediatric to adult sizes, and allows for precise positioning during implantation. Refer to the detailed specifications in the documentation to select the appropriate model for your patient’s requirements.
What storage requirements should I follow to maintain the integrity of these devices before use?
While the exact storage instructions are outlined in the accompanying documentation, sterile single-use or reusable devices like these typically require protection from moisture, extreme temperatures, and physical damage. Ensure they are stored in their original packaging, away from direct sunlight or contaminants, and follow any expiration or shelf-life guidelines provided to maintain sterility and functionality.
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: pacing leads guide wires and various accessories, PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES 510 (k) K003072 ..., PDF K003072 - Pacing Leads, Guide Wires, and Various Accessories
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003072 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K003072 24 fields · synced Sep 20, 2026