Selectra 3D Lead Delivery System (443624-443629, 451789-451791) +2 more models
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240787 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
- Models / Variants
- Selectra Slitter Tool (383119) FDA 510(k)Selectra Accessory Kit (375518) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Selectra 3D Lead Delivery System is a lead delivery catheter system designed for precise implantation of pacing leads, including His-bundle pacing. It combines a 3D catheter with a dedicated slitter tool and accessory kit to enhance maneuverability and accuracy during cardiac procedures. The system is engineered to simplify lead positioning in complex anatomical regions, improving procedural outcomes.
This system is supplied as a reusable medical device, intended for use in electrophysiology laboratories under sterile conditions. The Selectra 3D Lead Delivery System (443624-443629, 451789-451791) is paired with the Selectra Slitter Tool (383119) and Accessory Kit (375518) for compatibility. It has received FDA 510(k) clearance under the Traditional pathway, classified under product code DQY for cardiovascular devices. Storage and handling must adhere to manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
Is the Selectra 3D Lead Delivery System designed for single-use or reusable procedures, and how should it be handled to maintain sterility?
The Selectra 3D Lead Delivery System is explicitly designed as a reusable medical device, intended for use in electrophysiology labs under sterile conditions. Since it is reusable, it must be carefully cleaned, sterilized, and stored according to Biotronik’s manufacturer guidelines to ensure both sterility and functionality for repeated procedures. The system’s compatibility with the Selectra Slitter Tool and Accessory Kit further supports its sterile-use protocol during each procedure.
What specific models or part numbers are included in the Selectra 3D Lead Delivery System, and how do they pair with the slitter tool and accessory kit?
The Selectra 3D Lead Delivery System includes the following part numbers: 443624–443629 and 451789–451791. These models are designed to work exclusively with the Selectra Slitter Tool (383119) and the Selectra Accessory Kit (375518). The combination of these components ensures precise lead positioning, particularly in complex anatomical regions like His-bundle pacing, by enhancing maneuverability during implantation.
How does the Selectra 3D Lead Delivery System improve procedural outcomes compared to traditional lead delivery methods?
The Selectra 3D Lead Delivery System integrates a 3D catheter design with specialized tools (the slitter tool and accessory kit) to simplify navigation in intricate cardiac anatomy. This design reduces the need for manual adjustments, improving accuracy and efficiency during lead implantation—particularly for advanced pacing techniques like His-bundle pacing. The system’s enhanced maneuverability is intended to lower procedural complexity and optimize outcomes in electrophysiology labs.
What regulatory pathway was followed for FDA clearance of the Selectra 3D Lead Delivery System, and what does that mean for clinicians?
The Selectra 3D Lead Delivery System received FDA 510(k) clearance under the Traditional pathway, classified under product code DQY for cardiovascular devices. This means the device was evaluated by the FDA as substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards. Clinicians can rely on this clearance as confirmation that the system adheres to regulatory requirements for use in electrophysiology procedures.
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: Selectra 3D Catheters | Biotronik, Selectra - Biotronik, Selectra 3D Lead Delivery System (443624-443629, 451789-451791 ..., selectra 3d lead delivery system 443624-443629 451789-451791 selectra ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240787 | Class II | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K240787 24 fields · synced Oct 6, 2026