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Tad And Tad II Tapered Guide Wires

FDA 510(k)

Class II (US FDA 510(k))

510(k) K083732

by Abbott Vascular

Identifiers

510(k) Number
K083732 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 Tad and Tad II Tapered Guide Wires are peripheral guide wires designed to cross tight lesions and acute angles while negotiating vessels sensitive to spasm. These devices combine shaft support with a soft tip and shaping ribbon to provide precise steerability and crossing performance in complex or calcified lesions.

The system features an atraumatic guide wire tip and a hydrophobic coating to provide lubricity during use. Available in sizes ranging from .035 to .018 inches, these guide wires are designed to provide distal support across a range of anatomies. This device has received FDA 510k clearance.

Frequently asked questions

What are the Tad and Tad II Tapered Guide Wires used for?

These peripheral guide wires are designed to cross tight lesions and navigate acute angles in the vasculature. They are specifically engineered to provide shaft support while remaining gentle enough for vessels that are sensitive to spasm, making them suitable for complex or calcified lesions.

What size options are available for these guide wires?

The Tad and Tad II Tapered Guide Wires are available in a range of sizes from .035 to .018 inches. This variety allows clinicians to select the appropriate diameter to provide the necessary distal support across different patient anatomies.

What features contribute to the steerability of these wires?

The devices combine a supportive shaft with a soft tip and a shaping ribbon. This construction is designed to provide precise steerability and crossing performance, while the inclusion of a hydrophobic coating ensures the necessary lubricity during clinical use.

What is the regulatory status of the Tad and Tad II Tapered Guide Wires?

The Tad and Tad II Tapered Guide Wires have received FDA 510k clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

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: TAD™ II Tapered Guide Wire - Abbott Cardiovascular, Abbott Peripheral Interventional Guidewires, DeviceMD - TAD™ Tapered Guide Wire System, PDF Abbott Vascular Peripheral Guide Wires

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Abbott Vascular

Sources (1)

  • FDA 510(k) K083732 24 fields · synced Sep 22, 2026