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Acs.018 Hi-Torque Floppy Guide Wire - Acs Hi-Torque Floppy Extra Support Guide …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K934602

by Advanced Cardiovascular Systems, Inc.

Identifiers

510(k) Number
K934602 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)

This device is a guide wire, catheter type, used in cardiovascular procedures. It is designed to provide torque control and flexibility for navigating vascular pathways during catheter-based interventions.

The device is supplied as a single-use, sterile guide wire with a diameter of 0.018 inches. It received FDA 510(k) clearance K934602 on December 16, 1993, and is classified under product code DQX for cardiovascular guide wires.

Frequently asked questions

What is the ACS.018 HI-TORQUE FLOPPY GUIDE WIRE used for?

This guide wire is used in cardiovascular procedures to provide torque control and flexibility when navigating vascular pathways during catheter-based interventions, helping clinicians steer catheters through blood vessels with precision.

How is the ACS.018 HI-TORQUE FLOPPY GUIDE WIRE supplied and is it reusable?

The device is supplied as a single-use, sterile guide wire, meaning it is intended for one procedure only and must be discarded after use to prevent infection and ensure performance integrity.

What are the key specifications of the ACS.018 HI-TORQUE FLOPPY GUIDE WIRE?

The guide wire has a diameter of 0.018 inches, is designed for torque control and flexibility, and was cleared under FDA 510(k) K934602 on December 16, 1993, classified under product code DQX for cardiovascular guide wires.

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: Acs.018 Hi-torque Floppy Guide Wire - Acs Hi-torque Floppy Extra ..., Acs.018 Hi-torque Floppy Guide Wire - Acs Hi-torque Floppy Extra ..., ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - fda.report, ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH (K864585 ... - fda ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Advanced Cardiovascular Systems, Inc.

Sources (1)

  • FDA 510(k) K934602 24 fields · synced Oct 1, 2026