HYDRO-SELECT GUIDEWIRE

K954642 · Microvena Corp. · DQX · Dec 17, 1996 · Cardiovascular

Device Facts

• Record ID: K954642
• Device Name: HYDRO-SELECT GUIDEWIRE
• Applicant: Microvena Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The HyTek Guidewire is intended for general intravascular use to aid in the selective placement of catheters in the coronary and peripheral and visceral vasculature during diagnostic and/or therapeutic procedures.

Device Story

HyTek Hydrophilic Guidewire; intravascular device for catheter placement assistance. Nitinol core; continuous wire from distal tip to proximal shaft. Distal tip tapered for flexibility; gold-plated tungsten composition. Hydrophilic coating applied for lubricity. Used by clinicians in diagnostic/therapeutic procedures. Facilitates navigation through coronary, peripheral, and visceral vasculature.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included tensile strength, torqueability, torque strength, tip flexibility, and coating adhesion.

Technological Characteristics

Nitinol (nickel-titanium alloy) core; gold-plated tungsten distal tip; hydrophilic coating. Dimensions: tapered distal tip. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing diagnostic or therapeutic intravascular procedures requiring catheter placement in coronary, peripheral, or visceral vasculature.

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

• HydroTorque™ Guide Wire (K935232)
• ACS HI-TORQUE Guidewires
• The "NINER" .009" PTCA Guidewire (K952860)
• The M-PATH PTCA Guidewire (K946356)

Submission Summary (Full Text)

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K95 4642
Dec. 17, 1996

# 510(k) SUMMARY

Contact/Submitter: Christine M. Busch, Regulatory Affairs Associate
Date Prepared: December 12, 1996
Trade Name: The "HyTek" Hydrophilic Guidewire
Common Name: Guidewire
Classification Name: Wire Guide Catheter (per 21 CFR 870.1330)

**Predicate Devices:**
HydroTorque™ Guide Wire (K935232)
ACS HI-TORQUE Guidewires
The "NINER" .009" PTCA Guidewire (K952860)
The M-PATH PTCA Guidewire (K946356)

**Device Description:** The shaft of the HyTek Guidewire is constructed of Nitinol (nickel titanium alloy). The Nitinol core is a continuous piece of wire extending from the distal tip to the proximal shaft. The distal tip is tapered to provide flexibility and softness. The distal tip is composed of gold plated tungsten wire. The guidewire is coated with a hydrophilic coating to enhance lubricity.

**Intended Use:** The HyTek Guidewire is intended for general intravascular use to aid in the selective placement of catheters in the coronary and peripheral and visceral vasculature during diagnostic and/or therapeutic procedures.

## Functional/Safety

**Testing:** The HyTek Guidewire successfully underwent all functional and safety testing including tensile strength, torqueability and torque strength, tip flexibility and coating adhesion testing.

**Conclusion:** The HyTek Guidewire is substantially equivalent to the predicate devices based on the results of the functional testing.

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