Identifiers
- 510(k) Number
- K142393 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 Predicate III Guidewire is a cardiovascular guidewire intended to provide navigation and support during intravascular procedures. It is used to facilitate the delivery of catheters and other interventional devices within the vascular system.
The guidewire was cleared through an FDA 510(k) submission (K142393) as a special clearance with a decision of substantially equivalent on 25 November 2014. It is supplied by Lake Region Medical and identified by product code DQX, reflecting its classification as a guidewire for cardiovascular applications.
Frequently asked questions
What is the Predicate III Guidewire used for?
The Predicate III Guidewire is designed to provide navigation and support during intravascular procedures, facilitating the delivery of catheters and other interventional devices within the vascular system.
How is the Predicate III Guidewire supplied?
The Predicate III Guidewire is supplied by Lake Region Medical and is identified by product code DQX, reflecting its classification as a guidewire for cardiovascular applications.
What is the regulatory status of the Predicate III Guidewire?
The Predicate III Guidewire was cleared through an FDA 510(k) submission (K142393) as a special clearance with a decision of substantially equivalent on November 25, 2014.
Is the Predicate III Guidewire single-use or reusable?
The device data does not specify whether the Predicate III Guidewire is designed for single-use or multiple uses, so this information would need to be obtained directly from the manufacturer.
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: PDF Predicate III Special 510(k) - NonVascular, Predicate III Guidewire 510 (k) K142397 - FDA.report, PREDICATE III GUIDEWIRE (K142393) — FDA 510(k) | Innolitics, FDA 510 (k) Applications Submitted by Lake Region Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142393 | Class II | Active |
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Manufacturer
- Manufacturer
- Lake Region Medical
Sources (1)
- FDA 510(k) K142393 24 fields · synced Oct 6, 2026