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HI-TORQUE FLEX-T GUIDE WIRE - 05

FDA 510(k)

Class II (US FDA 510(k))

510(k) K083738

by Abbott Vascular

Identifiers

510(k) Number
K083738 FDA 510(k)
FDA Product Code
DQX FDA 510(k)
Models / Variants
1012067-01 FDA 510(k)
02 FDA 510(k)
03 FDA 510(k)
04 FDA 510(k)
05 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 Hi-Torque Flex-T Guide Wire is a manual catheter guide wire used by physicians during percutaneous peripheral vascular procedures. It is inserted into the vasculature to facilitate the navigation and placement of diagnostic or interventional catheters. The device features extra support and 1:1 torque with a shapeable core-to-tip design.

The device is supplied in various models including 1012067-01, 02, 03, 04 and 05, with specifications including .018" x 145cm. It is authorized under FDA 510K K083738 and is manufactured by Abbott Vascular. The device is intended for use in peripheral vascular procedures and is part of Abbott's supportive guidewires product line.

Frequently asked questions

What is the Hi-Torque Flex-T Guide Wire used for?

The Hi-Torque Flex-T Guide Wire is a manual catheter guide wire used by physicians during percutaneous peripheral vascular procedures. It is inserted into the vasculature to facilitate the navigation and placement of diagnostic or interventional catheters.

What are the specifications of the Hi-Torque Flex-T Guide Wire?

The device is supplied in various models including 1012067-01, 02, 03, 04 and 05, with specifications including .018" x 145cm. It features extra support and 1:1 torque with a shapeable core-to-tip design.

Is the Hi-Torque Flex-T Guide Wire single-use or reusable?

The device data does not specify whether the Hi-Torque Flex-T Guide Wire is single-use or reusable. For proper usage instructions and sterilization information, please refer to the manufacturer's documentation or contact Abbott Vascular directly.

What is the regulatory status of the Hi-Torque Flex-T Guide Wire?

The Hi-Torque Flex-T Guide Wire is authorized under FDA 510K K083738 with a decision code of SESE (Substantially Equivalent) and was reviewed by the Cardiovascular advisory committee. It is manufactured by Abbott Vascular.

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: Hi-Torque Flex-T™ Guidewires | Abbott, Hi-torque Flex-t Guide Wire, Models 1012067-01, 02, 03, 04 and 05, Hi-torque Flex-t Guide Wire, Models 1012067-01, 02, 03, 04 and 05, Hi-Torque Flex-T Guide Wire System - .018" x 145cm, Peripheral Guide Wires Ordering | Abbott

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Abbott Vascular

Sources (1)

  • FDA 510(k) K083738 24 fields · synced Sep 27, 2026