STARCLOSE HEX-HUB DILATOR

{0}------------------------------------------------ K062 554 ## APPENDIX A. 510(k) SUMMARY - … | A. Sponsor/Submitter: | Abbott Vascular Devices<br>400 Saginaw Drive<br>Redwood City, CA 94063 | FEB 6 200 | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | B. Contact Person: | Daun Putnam<br>Regulatory Project Manager<br>Phone:(650) 474-3323<br>Fax:(650) 474-3041 | | | Date of Submission: | August 25, 2006 | | | Device Trade Name: | StarClose 6F Dilator | | | Device Common Name: | Vessel Dilator | | | Device Classification: | Class II | | | Regulation Number: | 21 CFR 874.1310 | | | Classification Name: | Vessel, Dilator, for Percutaneous Catheterization | | | Product Code: | DRE | | | Predicate Device: | Encapsulon Vessel Dilators (K840641) and Super Sheath Introducer Sheath (K052557) | | | Intended Use: | The StarClose 6F Dilator is intended for use in procedures requiring percutaneous introduction of intravascular devices. | | | Device Description: | The Abbott Vascular StarClose 6F Dilator is a tapered plastic tube with a hub to facilitate handling and an interior channel sized to accept a 0.038 inch guidewire. The dilator goes inside one of the StarClose sheaths to provide support while gaining access to blood vessels prior to catheterization procedures. | | | Summary of Substantial<br>Equivalence: | Abbott Vascular has submitted information on indications for use, design and principle of operation, biocompatibility and performance characteristics to establish that StarClose 6F Dilator is substantially equivalent to currently marketed predicate devices.<br>StarClose 6F Dilator has the same intended use as the predicate devices. Results of scientific testing have ensured that all materials are biocompatible no new adverse effects were introduced and | | {1}------------------------------------------------ physical properties are appropriate for the intended use. Non-clinical testing was conducted. 1 1 1 : In conclusion, StarClose 6F Dilator has been shown to be substantially equivalent to the Class II predicate devices upon which the dilator is based. . {2}------------------------------------------------ . . . Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## FEB 6 2007 Abbott Vascular Inc. c/o Veronica Kocken 400 Saginaw Drive Redwood City, CA 94063 Re: K062554 Trade Name: Vessel Dilator Regulation Number: 21 CFR 874.1310 Regulation Name: Vessel, Catheter, for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: December 19, 2006 Received: December 20, 2006 Dear Ms. Kocken: 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. 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 or any Federal statutes and regulations administered by other Federal agencies. You must {3}------------------------------------------------ ## Page 2 - Mr. Wagner comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, R. lochner Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## APPENDIX B. INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K__________________________________________________________________________________________________________________________________________________ 062554 Device Name: The StarClose 6F Dilator Indications For Use: The StarClose 6F Dilator is intended for use in procedures requiring percutaneous introduction of intravascular devices. × Prescription Use OR (Per 21 CFR 801.109) (Optional Format 1-2-96) Over-The-Counter Use (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) uma R. W. Wainer (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K062554