MiVi Neuroscience LLC / PET / K140557 Trade / Medical Inc. / 1 PSC Publishing / / /
Facility
New Hampshire Avenue Document Control Center / / /
IndustryTerm
stainless steel / announcements concerning your device / coronary and neuro vascular systems / contrast agents or other devices / predicate device / manufacturing practice requirements / stainless steel braid / marketed predicate devices / manufacturing practice / blood contacting device / Internet address http /
MedicalCondition
sterility assurance level / flushing / sterility / arterial disease / Cytotoxicity - ISO MEM Elution Assay Irritation / MS / Extract Methods Hemocompatibility Thrombosis / /
MedicalTreatment
PTCA / catheter / catheters / /
Organization
Division of Postmarket Surveillance / Division of Industry and Consumer Education / Division of Neurological and Physical Medicine Devices / MS Director Division of Neurological / Food and Drug Administration / Center for Devices and Radiological Health / Neurological and Physical Medicine Devices Office / Device Evaluation Center for Devices / European Union / 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
Michelle Straight / Silver Spring / Carlos L. Pena / Carlos L. Peña / / /
Position
VP of Quality & Regulatory / Vice President of RA/QA Phone / /
Microsoft Word - K140557 Summary letterhead[removed]Indication and BioC update