HARMAC BALLOON ANGIOGRAPHIC CATHETER

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service OCT 16 1997 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Michael Guzzo Quality Assurance Engineer Harmac Medical Products, Inc. 2201 Bailey Avenue Buffalo, New York 14211-1797 Re: K962829 Harmac Balloon Angiographic Catheter Regulatory Class: II (two) Product Code: DQO Dated: August 22, 1997 Received: August 29, 1997 Dear Mr. Guzzo: 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. {1} 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 and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} # INDICATIONS FOR USE 510(K) Number: K962829 Device Name: Harmac Balloon Angiographic Catheter Indications for Use: "The Balloon Angiographic catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be used to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart." Contraindications: "This device is not designed, sold, or intended for use except as indicated." PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation Tara A. Ryn (Division Signor) Division of and Neurologic 510(k) Number K962829 Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use Harmac Medical Products, Inc. K962829 Attachment 4