CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM

K970392 · Cordis Corp. · DRE · Apr 24, 1997 · Cardiovascular

Device Facts

• Record ID: K970392
• Device Name: CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
• Applicant: Cordis Corp.
• Product Code: DRE · Cardiovascular
• Decision Date: Apr 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Intended Use

The Avanti + Catheter Sheath Introducer is indicated for use in arterial and venous 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

Catheter sheath introducer system; provides vascular access for intravascular devices; maintains hemostasis via integrated valve; includes sideport for fluid infusion and blood withdrawal. Used in clinical settings by physicians for percutaneous procedures. Facilitates device insertion while minimizing blood loss.

Clinical Evidence

Bench testing only; no clinical data.

Technological Characteristics

Catheter sheath introducer system; includes valve for hemostasis and sideport for fluid/blood access. Materials previously validated for biocompatibility in predicate devices.

Indications for Use

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

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Predicate Devices

• Brite Tip Catheter Sheath Introducer (K954595)
• Avanti™ Catheter Sheath Introducer (K945616)

Submission Summary (Full Text)

{0}

00-00035

K970392

# PREMARKET NOTIFICATION 510(k)
Cordis Corporation
Avanti + Catheter Sheath Introducer

## SUMMARY OF SAFETY AND EFFECTIVENESS

APR 24 1997

### I. General Provisions

Common or Usual Name: Catheter Sheath Introducer or Sheath Introducer System
Proprietary Name: Cordis Avanti + Catheter Sheath Introducer System

### II. Name of Predicate Devices

Brite Tip Catheter Sheath Introducer, K 9954595, October 02, 1995
Avanti™ Catheter Sheath Introducer, K 945616, November 14, 1994

### III. Classification

Class II

### 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 Avanti + Catheter Sheath Introducer is indicated for use in arterial and venous 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 previously performed on the materials used for the Cordis Avanti + Catheter Sheath Introducer. No new tests were performed, since all materials had been successfully tested on previously concurred devices.

{1}

00-00036

PREMARKET NOTIFICATION 510(k)
Cordis Corporation
Avanti + Catheter Sheath Introducer

VII. Summary of Substantial Equivalence

The Cordis Avanti + Catheter Sheath Introducer is similar in design, construction, indication for use, and performance characteristics to other commercially available sheath introducers.