THE HAMMER MODEL H100

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the caduceus symbol. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 2 8 2002 Mr. Richard Brand Caso Tenacore Holdings, Inc. 23266 Via Ronda Mission Viejo, CA 92691 Re: K012041 Trade Name: The Hammer, Model H100 Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: December 17, 2001 Received: January 7, 2002 Dear Mr. Caso: 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 for abound of the 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 - Mr. Richard Brand Caso Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or any I edolul statuates and enginements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 6077, adoning (21 CFR Part 820); and if applicable, the electronic forth in the quality by systems (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you'll began made of substantial equivalence of your device to a legally premated notificated with 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of Ice Car (301) 594-4646. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-4639 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation on the our many responsibilities under the Act may be obtained from the Oivision of Small Manufacturers, International and Consumer Assistance at 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, A. D. Tech uckerman, M.D. Sram D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ FAXED 3/08/02 Page 1 of K012041 . 510(k) Number (if known): Device Name: The Hammer Model (H100) Indications For Use: Indicated in the compression of the femoral artery or vein after catherization. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) **Division of Cardiovascular & Respiratory Devices** **510(k) Number** K012041 (Optional Format 3-10-98) **Prescription Use** **(Per 21 CFR 801.109)** {3}------------------------------------------------ ## Page 2 - Mr. Richard Brand Caso Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be advisou that I Dr o sean that your device complies with other requirements of the Act that I DIT has made a cond regulations administered by other Federal agencies. You must of any I catal stututed and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by bections (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and noyal to FDA finding of substantial equivalence of your device to a legally promation houring 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Far 3646. Additionally, for questions on the promotion and advertising of Compinatee at (301) 0 - 1 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Thisoranenes on your responsibilities under the Act may be obtained from the Oiner general international and Consumer Assistance at 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, the D. Keith MD Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure