CORDIS ST STEERABLE GUIDEWIRE

K963214 · Cordis Corp. · DQX · Nov 13, 1996 · Cardiovascular

Device Facts

• Record ID: K963214
• Device Name: CORDIS ST STEERABLE GUIDEWIRE
• Applicant: Cordis Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: Nov 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Cordis ST Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

Device Story

Steerable guidewire used in angiographic procedures; facilitates introduction and positioning of catheters and interventional devices within coronary and peripheral vasculature. Device consists of stainless steel corewire and radiopaque coil; shaft coated with PTFE. Operated by physicians during interventional procedures to navigate vasculature. Provides mechanical support and guidance for secondary devices; enables precise placement for diagnostic or therapeutic interventions.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO-10993 (Blue Book Memorandum G95-1) requirements.

Technological Characteristics

Stainless steel corewire; radiopaque coil; PTFE shaft coating. Class II device (21 CFR 870.1330). Biocompatibility verified per ISO-10993.

Indications for Use

Indicated for patients undergoing angiographic procedures requiring catheter or interventional device placement within coronary and peripheral 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

• Cordis WIZDOM Steerable Guidewire (K953760)
• ACS HI-TORQUE FLOPPY/FLOPPY II/Intermediate/Standard Guide Wire (K881897)

Submission Summary (Full Text)

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NOV 13 1995
00-00020
K963214

# PREMARKET NOTIFICATION
Cordis Corporation
ST Steerable Guidewire

## SUMMARY OF SAFETY AND EFFECTIVENESS

### I. General Provisions

Common or Usual Name: Catheter Guide Wire

Proprietary Name: Cordis ST Steerable Guidewire

### II. Name of Predicate Devices

Cordis WIZDOM Steerable Guidewire (K953760)
ACS HI-TORQUE FLOPPY/FLOPPY II/Intermediate/Standard Guide Wire (K881897)

### III. Classification

Catheter Guide Wire, Class II - 21 CFR 870.1330
74DQX - Cardiovascular Devices

### IV. Performance Standards

Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.

### V. Intended Use and Device Description

The Cordis ST Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

The Cordis ST Steerable Guidewire incorporates a stainless steel corewire and radiopaque coil. The shaft is coated with PTFE.

### VI. Biocompatibility

All materials have been tested as specified by the FDA modified matrix of ISO-10993 (Blue Book Memorandum G95-1). All material demonstrated compatibility with biological tissue by meeting the acceptance requirements stipulated in the test protocols.