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Balloon catheter / Angioplasty / Percutaneous / Stent / Balloon / Medicine / Interventional radiology / Catheter


L23 1 Ostial Corporation 5 10(k) Notification: Flash PTA Balloon Dilatation Catheter SECTION 5:
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Document Date: 2012-10-09 13:29:38

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City

Mountain View / /

Company

K122379 Trade / Ostial Corporation / Radiological Health Enclosure Ostial Corporation / L23 1 Ostial Corporation / /

Event

FDA Phase / /

IndustryTerm

test protocols / announcements concerning your device / predicate device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / CDRH' s office of Surveillance / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / Cardiovascular Devices Office / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Center for Devices / Device Evaluation Center for Devices and Radiological Health Enclosure Ostial Corporation / /

Person

Silver Spring / Brain D. Zuckerman / Kaitlin von Hoffmann / Kaitlin von Hoffmannm / /

/

Position

Director Division / M.D. Director Division / /

Product

ISO Acute Systemic Injection / K120738 / /

ProvinceOrState

Maryland / California / /

Technology

design verification / radiation / Flash / test protocols / /

URL

http /

SocialTag