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Gt2 Fusion Guide Wire (Ntlhlj180 +3 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K001969

by Medtronic Vascular

Identifiers

510(k) Number
K001969 FDA 510(k)
FDA Product Code
DQY FDA 510(k)
Models / Variants
Ntlhlj180 FDA 510(k)
Ntlhls180 FDA 510(k)
Ntlhlj300 FDA 510(k)
Ntlhls300 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 GT2 Fusion Guide Wire is a catheter, percutaneous, designed for use in cardiovascular procedures. It is a hydrophilic, floppy-tipped guidewire intended to facilitate navigation through complex vascular anatomy, including tortuous or calcified vessels, during interventional radiology or cardiology procedures.

This device is supplied as a single-use, sterile product and is classified under FDA product code DQY as a Class II device with special controls. It is intended for use in controlled clinical settings, such as catheterization labs, and requires proper storage to maintain sterility. The device holds an FDA 510(k) clearance (K001969) under the Substantially Equivalent determination, with a review by the Cardiovascular (CV) Advisory Committee.

Frequently asked questions

What types of vascular challenges is the GT2 Fusion Guide Wire specifically designed to help navigate during procedures?

The GT2 Fusion Guide Wire is engineered with a hydrophilic, floppy-tipped design to assist in navigating complex vascular anatomy, particularly in tortuous (twisted or winding) or calcified vessels. Its flexibility and lubricity make it ideal for interventional radiology or cardiology procedures where standard guide wires may struggle to traverse difficult pathways.

Are the GT2 Fusion Guide Wire models interchangeable, or do they differ in key specifications?

The GT2 Fusion Guide Wire comes in four models: NTLHLJ180, NTLHLS180, NTLHLJ300, and NTLHLS300. While the exact differences between the models (such as length or tip flexibility) aren’t detailed in the provided data, the numbering suggests variations in length (180 vs. 300) and potentially other technical specifications like tip design (J vs. S). Clinicians should refer to the product documentation for precise model-specific details.

How should the GT2 Fusion Guide Wire be stored to ensure it remains sterile and functional?

Since the GT2 Fusion Guide Wire is a single-use, sterile product, it must be stored in its original packaging until use to preserve sterility. The packaging should be kept in a clean, dry environment, away from direct sunlight or extreme temperatures, as recommended for medical devices. Always check the expiration date on the packaging before use.

What kind of clinical settings is the GT2 Fusion Guide Wire intended for, and why?

The GT2 Fusion Guide Wire is designed for use in controlled clinical settings like catheterization labs, where interventional radiology or cardiology procedures are performed. Its specialized design for navigating complex vessels requires precision and sterile conditions, which are standard in these specialized environments.

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: Gt2 Fusion Guide Wire, Model Ntlhlj180,Ntlhls180, Ntlhlj300, Ntlhls300 ..., GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,... (K001969) - FDA 510 (k), Gt2 Fusion Guide Wire, Model Ntlhlj180,Ntlhls180, Ntlhlj300, Ntlhls300 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K001969 24 fields · synced Oct 6, 2026