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

K961917 · Medtronics Interventional Vascular · DQX · Nov 20, 1996 · Cardiovascular

Device Facts

• Record ID: K961917
• Device Name: MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)
• Applicant: Medtronics Interventional Vascular
• Product Code: DQX · Cardiovascular
• Decision Date: Nov 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended 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.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) requiring the introduction and placement of interventional catheters.

Regulatory Classification

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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