OCCLUSION CLAMP** DEVICE

{0} K964251 MAY 23 1997 UNITED STATES SURGICAL CORPORATION 510(k) Premarket Notification AUTO SUTURE* Occluding Clamp** Device SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS: SUBMITTER: United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856 (203) 845-1000 CONTACT PERSON: Victor Clavelli (203) 845-4543 DATE PREPARED: October 16, 1996 CLASSIFICATION NAME: Vascular Clamp COMMON NAME: AUTO SUTURE* Occluding Clamp** device PROPRIETARY NAME: Trademark name not yet determined PREDICATE DEVICE: RMI™ YACOUBIAN™ Clamp, K920936 DEVICE DESCRIPTION: The AUTO SUTURE* Occluding Clamp** device is a vascular clamp applier. INTENDED USE: The device is intended for use in those patients undergoing coronary artery bypass surgery when the surgeon determines that it is desirable to temporarily occlude a coronary artery to optimize the exposure during the anastomosis. MATERIALS: The AUTO SUTURE* Occluding Clamp** device is comprised of materials which are in accordance with ISO Standard # 10993-1. PERFORMANCE: THE AUTO SUTURE* Occluding Clamp** device was tested both in-vitro and in-vivo to evaluate its performance. The results of the testing demonstrate the subject device to be safe and effective. * Trademark of United States Surgical Corporation ** Trademark name not yet determined PAGE 12 {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 23 1997 Mr. Victor Clavelli Sr. Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856 Re: K964251 AUTO SUTURE* Occluding Clamp** Device Regulatory Class: II (two) Product Code: DXC Dated: February 21, 1997 Received: February 24, 1997 Dear Mr. Clavelli: 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in {2} 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. 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 at (301) 443-6597. 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} # UNITED STATES SURGICAL CORPORATION 510(k) Premarket Notification AUTO SUTURE* Occluding Clamp** Device ## II. INDICATIONS FOR USE: 510(k) Number (if known): k964251 Device Name: AUTO SUTURE* Occluding Clamp** device Indications for use: The AUTO SUTURE* Occluding Clamp** device is intended for use in those patients undergoing coronary artery bypass surgery when the surgeon determines that it is desirable to temporarily occlude a coronary artery to optimize the exposure during the anastomosis. (Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation  (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number k964251 Prescription Use: ☑ OR Over-The-Counter Use: PAGE 3 * Trademark of United States Surgical Corporation ** Trademark name not yet determined