Modification To Endovascular Guide Wire
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K043457 FDA 510(k)
- FDA Product Code
- DQX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1330 FDA 510(k)
- Regulation Number
- 870.1330 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Assert Guide Wire is a modification to an endovascular guide wire, designed for use within the cardiovascular system. It is intended to assist in the introduction and positioning of over-the-wire catheters and therapeutic devices during intravascular procedures in coronary and peripheral vasculature. This device is classified under the endovascular catheter nomenclature, with modifications tailored for enhanced navigability and compatibility with robotic-assisted systems.
The device is supplied as a single-use, non-sterile instrument and requires pairing with the Stereotaxis Magnetic Navigation System for proper functionality. It is contraindicated for use in cerebral vasculature or with ferromagnetic interventional devices, including rotational atherectomy tools. The Assert Guide Wire is regulated under FDA 510(k) clearance (K043457) as a substantially equivalent modification to an existing endovascular guide wire, adhering to cardiovascular advisory committee standards. Storage and handling must comply with manufacturer guidelines to maintain device integrity.
Frequently asked questions
What is the Assert Guide Wire designed for?
The Assert Guide Wire is a modified endovascular guide wire specifically designed to assist in introducing and positioning over-the-wire catheters and therapeutic devices during intravascular procedures. It is tailored for use in coronary and peripheral vasculature, offering improved navigability and compatibility with robotic-assisted systems like the Stereotaxis Magnetic Navigation System. This makes it particularly useful in complex or minimally invasive procedures where precise control is required.
How is the Assert Guide Wire supplied and prepared for use?
The Assert Guide Wire is supplied as a single-use, non-sterile instrument. Before use, it must be sterilized by the healthcare provider according to standard medical sterilization protocols. Additionally, it is intended to be used exclusively in conjunction with the Stereotaxis Magnetic Navigation System to ensure proper functionality and safety during procedures.
Can the Assert Guide Wire be reused?
No, the Assert Guide Wire is explicitly designed for single-use only. Reusing this device could compromise its structural integrity, navigability, and sterility, potentially leading to adverse clinical outcomes. Always follow the manufacturer’s guidelines for proper disposal after a single use.
What are the key limitations or contraindications for using this guide wire?
The Assert Guide Wire is contraindicated for use in cerebral vasculature due to potential risks associated with its design and magnetic compatibility. Additionally, it should not be used with ferromagnetic interventional devices, such as rotational atherectomy tools, as these may interfere with its performance or safety. Always verify compatibility with the intended procedure and equipment before use.
How should the Assert Guide Wire be stored?
The Assert Guide Wire must be stored and handled according to the manufacturer’s guidelines to maintain its integrity and functionality. Since it is non-sterile, it should be kept in a clean, dry environment, protected from physical damage, moisture, and extreme temperatures. Proper storage ensures the device remains effective when needed for robotic-assisted 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: MODIFICATION TO ENDOVASCULAR GUIDE WIRE (K043457) — FDA 510 (k ..., PDF K043457 - Modification to Endovascular Guide Wire, Stereotaxis, PDF Special 510(k): Assert Guide Wire December 09, 2004 Stereotaxis, Inc ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043457 | Class II | Active |
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Manufacturer
- Manufacturer
- Stereotaxis, Inc.
Sources (1)
- FDA 510(k) K043457 24 fields · synced Oct 1, 2026