CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT

K962746 · Cordis Corp. · DYB · Oct 11, 1996 · Cardiovascular

Device Facts

• Record ID: K962746
• Device Name: CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT
• Applicant: Cordis Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Avanti™ Trans-Radial Catheter Sheath Introducer kit is intended for use in (radial) arterial procedures requiring percutaneous introduction of catheters and other intravascular devices. As with other currently marketed Cordis CSIs mentioned in this submission, these devices provide vascular access for various intravascular devices through the valve while simultaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.

Device Story

Kit provides vascular access for intravascular devices via radial artery; maintains hemostasis during procedure; allows fluid infusion and blood withdrawal via sideport. Used by physicians in clinical settings for percutaneous catheterization. Benefits include simplified radial access through inclusion of vessel dilator and needle.

Clinical Evidence

Bench testing only; biocompatibility testing performed on new materials.

Technological Characteristics

Catheter sheath introducer kit; includes sheath, dilator, and needle. Materials tested for biocompatibility. Class II device per 21 CFR 870.1340.

Indications for Use

Indicated for patients undergoing radial arterial procedures requiring percutaneous introduction of catheters and other intravascular devices.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Cordis Avanti™ Catheter Sheath Introducer (K945616)
• Cordis Avanti™ Catheter Sheath Introducer (K932733)
• Cordis Plus Catheter Sheath Introducer (K911794)
• Arrow Radial Artery Catheterization Set (K810675)

Submission Summary (Full Text)

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OCT 11 1996
K962746

# Summary of Safety and Effectiveness
Pursuant to Section 513(I) of the Federal Food, Drug, and Cosmetic Act

## I. General Provisions

Classification Name: Catheter Sheath Introducer (CSI) Kit

Common or Usual Name: Sheath Introducer Kit or Trans-Radial Introducer Kit

Proprietary Name: Cordis Avanti™ Trans-Radial Sheath Introducer Kit

Applicant Name and Address: Cordis
P.O. Box 025700
Miami, FL 33015-5700

## II. Name of Predicate Devices

Cordis Avanti™ Catheter Sheath Introducer K945616 and K932733
Cordis Plus Catheter Sheath Introducer K911794
Arrow Radial Artery Catheterization Set K810675

## III. Classification

Catheter Sheath Introducer Kits are Cardiovascular Diagnostic Devices and are classified as Class II devices according to 21 CFR 870.1340.

## IV. Performance Standards

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

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# V. Intended Use and Device Description

The Avanti™ Trans-Radial Catheter Sheath Introducer kit is intended for use in (radial) arterial procedures requiring percutaneous introduction of catheters and other intravascular devices. As with other currently marketed Cordis CSIs mentioned in this submission, these devices provide vascular access for various intravascular devices through the valve while simultaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.

# VI. Biocompatibility

All appropriate biocompatibility tests were performed on the new material used for the Trans-Radial CSI Kit. All other materials were tested on previously concurred devices and passed.

# VII. Summary of Substantial Equivalence

Except for the site of entry (radial instead of femoral) and the addition of the radial vessel dilator and needle (thus making it a complete kit), the Cordis Avanti™ Trans-Radial Catheter Sheath Introducer Kit has the same intended use as other sheath introducers already on the market (i.e., Cordis Avanti™ CSI and Cordis Plus CSI). In addition, the Avanti™ Trans-Radial CSI Kit is similar in its basic design, construction, and indication for use to currently marketed catheter sheath introducer systems.