(80 days)
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.
I am sorry, but the provided text from the Preamble Notification 510(k) for the Cordis Corporation Avanti + Catheter Sheath Introducer (K970392) does not contain any information regarding specific acceptance criteria for device performance or any studies conducted to prove that the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices based on design, construction, and intended use, and mentions biocompatibility testing previously performed on the materials. It explicitly states that "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act."
Therefore, I cannot fulfill your request for the detailed table and study information because it is not present in the provided text.
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00-00035
PREMARKET NOTIFICATION 510(k) Cordis Corporation Avanti + Catheter Sheath Introducer
SUMMARY OF SAFETY AND EFFECTIVENESS
APR 24 1997
l. General Provisions
Common or Usual Name: Catheter Sheath Introducer or Sheath Introducer System
Proprietary Name: Cordis Avanti + Catheter Sheath Introducer System
.. 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
ﺔ ﺍﻟﻤ
Class II
Performance Standards IV.
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.
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00-00036
PREMARKET NOTIFICATION 510(k) Cordis Corporation Avanti + Catheter Sheath Introducer
VII. Summary of Substantial Equivalence
ﮯ ﮐﮧ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺷﮩﺮ
ﺷﮩﺮ
The Cordis Avanti + Catheter Sheath Introducer is similar in design, construction, indication for use, and performance characteristics to other commercially available sheath introducers.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
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.(b)
Classification. Class II (performance standards).