Selectra CS Lead Introducer System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K110461 FDA 510(k)
- FDA Product Code
- DQY 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 CS Lead Introducer System is a family of guiding catheters specifically used for the placement of coronary sinus leads. It is designed to assist with lead delivery during implantation procedures.
The system is supplied by Biotronik, Inc. and has received FDA 510(k) clearance with a K number of K110461. It is intended for use in cardiovascular procedures and is available in various sizes to accommodate different clinical needs.
Frequently asked questions
What is the purpose of the Selectra CS Lead Introducer System?
The Selectra CS Lead Introducer System is a family of guiding catheters specifically designed to assist with the placement of coronary sinus leads during implantation procedures in cardiovascular interventions.
What sizes and models are available for the Selectra CS Lead Introducer System?
The Selectra CS Lead Introducer System is available in various sizes to accommodate different clinical needs during coronary sinus lead placement procedures, though specific size dimensions are not provided in the available data.
What regulatory clearance has the Selectra CS Lead Introducer System received?
The Selectra CS Lead Introducer System has received FDA 510(k) clearance with K number K110461, classified as substantially equivalent to predicate devices for cardiovascular procedures.
How is the Selectra CS Lead Introducer System supplied?
The Selectra CS Lead Introducer System is supplied by Biotronik, Inc., though the specific packaging, sterility status, and whether it's designed for single-use or reuse are not detailed in the provided information.
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 Catheters | Biotronik, Selectra - Biotronik, PDF Selectra Lead Introducer System APR 2 0 2011 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110461 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K110461 24 fields · synced Oct 1, 2026