CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

{0} 00-00026 K974448 # PREMARKET NOTIFICATION 510(k) Cordis, a Johnson and Johnson company Brite Tip® Catheter Sheath Introducer (Modification K971608) FEB 6 1998 ## SUMMARY OF SAFETY AND EFFECTIVENESS ### I. General Provisions Common or Usual Name: Catheter Sheath Introducer or Sheath Introducer System. Proprietary Name: Cordis Brite Tip® Catheter Sheath Introducer System. ### II. Name of Predicate Device Brite Tip® Catheter Sheath Introducer System, K971608. ### 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 line extensions for Brite Tip® Catheter Sheath Introducer System 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 materials used in the line extensions for Cordis Brite Tip® Catheter Sheath Introducer System had been successfully tested on previously concurred devices. Since all appropriate biocompatibility tests were previously performed on these materials, testing was not repeated. ### VII. Summary of Substantial Equivalence The modified Cordis Brite Tip® Catheter Sheath Introducer System is similar in design, constructions, indication for use, and performance characteristics to other commercially available sheath introducers. {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Rockville MD 20857 # FEB 6 1998 Ms. Ariel MacTavish Sr. Regulatory Affairs Associate Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700 Re: K974448 Brite Tip® Catheter Sheath Introducer System Regulatory Class: II (two) Product Code: 74 DYB Dated: November 24, 1997 Received: November 25, 1997 Dear Ms. MacTavish: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {2} This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours,  Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3} 00-00051 # PREMARKET NOTIFICATION 510(k) ## Cordis Corporation ## Brite Tip® Catheter Sheath Introducer 510(k) Number (if known): K974448 Device Name: Brite Tip Catheter Sheath Introducer Indications for Use: Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)  Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use