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.
{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.
