Identifiers
- 510(k) Number
- K110241 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 Endologix Guidewire is a vascular guidewire used to facilitate catheter placement and exchange in peripheral vasculature. It consists of a stainless steel core wire with a platinum coil, which may cover the entire core or the distal portion only.
The guidewire is supplied as a single-use device and is classified as a Class II device with product code DQX. It is stored at the manufacturer's address and is regulated under 21 CFR 870.1330. The device has been cleared by the FDA under the 510K clearance process, with clearance number K110241.
Frequently asked questions
What is the Endologix Guidewire used for?
The Endologix Guidewire is used to facilitate catheter placement and exchange in peripheral vasculature, providing a means to access and treat vascular conditions.
Is the Endologix Guidewire a single-use device?
Yes, the Endologix Guidewire is supplied as a single-use device, ensuring patient safety and preventing potential complications associated with reuse.
How is the Endologix Guidewire stored?
The Endologix Guidewire is stored at the manufacturer's address, which is 650 Pleasant St, Watertown, MA 02472, in the US.
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: ENDOLOGIX GUIDEWIRE (K110241) — FDA 510 (k) | Innolitics, K110241 FDA 510 (k) - ENDOLOGIX GUIDEWIRE, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110241 | Class II | Active |
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Manufacturer
- Manufacturer
- Techdevice Corporation
Sources (1)
- FDA 510(k) K110241 24 fields · synced Sep 26, 2026