← Product Code [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX) · K961917

# MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) (K961917)

_Medtronics Interventional Vascular · DQX · Nov 20, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K961917

## Device Facts

- **Applicant:** Medtronics Interventional Vascular
- **Product Code:** [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX.md)
- **Decision Date:** Nov 20, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1330
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Indications for Use

The Medtronic® MUSTANG™ Steerable Guide Wire is for use in introducing and placing interventional catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

## Device Story

Steerable guide wire; 0.014" diameter; used for introducing/placing interventional catheters during PTCA/PTA procedures. Features proximal polymer coating; distal 33 cm lubricious coating; radiopaque distal spring. Sterile; single-use; disposable. Operated by interventional cardiologists/radiologists in cath lab setting. Facilitates catheter navigation through coronary/peripheral vasculature; provides trackability and torque control for lesion access.

## Clinical Evidence

Bench testing only. No clinical data provided. Testing included tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity, catheter compatibility, and biocompatibility.

## Technological Characteristics

0.014" (0.36 mm) diameter steerable wire. Materials: proximal polymer coating, distal lubricious coating, radiopaque distal spring. Sterile, single-use. Mechanical device; no software or energy source.

## Regulatory Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

## Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

## Predicate Devices

- ACS® Hi Torque Floppy II® Guide Wire
- Scimed® Sceptor™ Floppy Guide Wire

## Submission Summary (Full Text)

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NOV 20 1996
K961917
510(k) Notification
Medtronic® Mustang™ Steerable Guide Wire

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
(Pursuant to Section 12, Safe Medical Devices Act of 1990)

1. The trade or proprietary name of the device is the Medtronic® MUSTANG™ Steerable Guide Wire. The common or classification name is Coronary Guidewire.

2. The Medtronic® MUSTANG™ Steerable Guide Wire is for use in introducing and placing interventional catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).

3. The Medtronic® MUSTANG™ Steerable Guide Wire is a guide wire having a maximum diameter of 0.014" (0.36 mm). The proximal shaft is coated with a polymer and the distal 33 cm contains a lubricious coating. The distal segment of the wire contains a spring which is radiopaque. The MUSTANG™ is provided sterile, and is intended for one procedure use only (disposable).

4. In vitro testing included tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity and catheter compatibility. Testing was performed to assess the biocompatibility of the device.

5. Test results verified that the MUSTANG™ meets all of the applicable specifications and is deemed adequate for the intended use. The MUSTANG™ is considered to be substantially equivalent to the following devices:

ACS® Hi Torque Floppy II® Guide Wire

Scimed® Sceptor™ Floppy Guide Wire

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K961917](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K961917)

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