Acute Toxicity (this was done on Rotaglide alone ViperSlide alone Rotaglide exposed to the device and ViperSlide exposed to the device) Bayer Medical Care Inc. / Other Predicate Devices JETSTREAM Systems / MCW Bayer Medical Care Inc. / Bayer Medical Care Inc. / JETSTREAM Systems / Stainless Steel / K133023 Trade / 1 PSC Publishing / / /
Event
FDA Phase / /
Facility
New Hampshire Avenue Document Control Center / / /
IndustryTerm
peripheral treatment site / announcements concerning your device / predicate devices / predicate device / manufacturing practice requirements / rotational atherectomy catheter systems / marketed predicate devices / manufacturing practice / subject devices / Internet address http /
Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Center for Devices and Radiological Health / Cardiovascular Devices Office / Device Evaluation Center for Devices / Department of Health and Human Services Food and Drug Administration office of Chief Information officer Paperwork Reduction Act / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Devices and Radiological Health Enclosure DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved / CDRH's office of Surveillance / /
Person
Bram D. Zuckerman / Silver Spring / Kenneth J. Cavanaugh / George Lucas / / /
Position
system controller / SUMMARY General / Director Division / M.D. Director Division / /
Microsoft Word - 510k summary for G5 modified 8.15.14docx.docx