SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 7 2005 Facile Medical, Inc. c/o Albert Rego, Ph.D. 27001 La Paz, Suite 312 Mission Viejo, CA 92691 Re: K042308 Trade Name: Sheath-in-Sheath Catheter Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: Class II (two) Product Code: DYB Dated: August 9, 2004 Received: August 25, 2004 Dear Dr. Rego: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Albert Rego, Ph.D. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated of a button and other requirements of the Act that FDA has made a determination that your device complies with other requirements of th that FDA has made a decernmanon that Jour as researced by other Federal agencies. You must of any Federal statutes and regulations adminities. but not limited to: registration and listing (21 comply with an the Act 3 requirements, mercesses canafacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 800); and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR Part 820); and if app 1000-1050 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (osetions over device as described in your Section 510(k) This letter will allow you to begin marketing your device as described in your I mis letter will anow you to organ manisang of substantial equivalence of your device to a legally premarket notheation. The PDA muling of bactualians 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), please If you desire specific advice 101 your as 1) 594-4648. Also, please note the regulation entitled, contact the Office of Comphalled at (80 ) x 1 x 7 x 7 807.97). You may obtain Misolalianing by reference to premaintentibilities under the Act from the Division of Small other general information on your responses in its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Baina R. Vochner (A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): _K042308 Device Name: Sheath-in-Sheath Catheter The Sheath-in Sheath Catheter is designed to facilitate the entry of Indications For Use: interventional devices into the vessels of the cardiovascular system. Prescription Use __ / (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Duna D. Vachner (Division : . ." Divis .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 510(n) . . . umber_K042308 Page 1 of ____________________________________________________________________________________________________________________________________________________________________