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Medical equipment / Coronary artery bypass surgery / Endoscopic vessel harvesting / Cannula / Medical device / Dissection / Title 21 of the Code of Federal Regulations / Premarket approval / Medicine / Cardiac surgery / Medical technology


Page 1 of 3 K[removed]Harvesting Cannula 510(k) Summary Prepared in accordance with 21 CPR Part[removed]
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Document Date: 2014-01-14 08:01:27

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File Size: 153,15 KB

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City

Wayne / /

Company

MAQUET Cardiovascular LLC / Kl32743 Trade / /

Currency

USD / /

Event

FDA Phase / /

Facility

Tool Adapter Port / /

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IndustryTerm

announcements concerning your device / predicate devices / predicate device / fimndamental scientific technology / lfyour device / arid coaguLlation device / marketed predicate devices / manufacturing practice / Internet address htW /

Organization

Division of Postmarket Surveillance / F.A.C.S. Acting Director Division / Center for Devices and Radlological Health / office of Surveillance / FDA / Surgical Devices Office / Division of Small Manufacturers / International and Consumer Assistance / K132743 Division / Device Evaluation Center for Devices and Radiological Health / /

Person

Mark Dinger / Joshua C.Nipper / Enclosure Binita S.Ashar / /

/

Position

Regulatory Affairs Specialist / /

Product

Harvesting Cannula / Drug / /

ProvinceOrState

New Jersey / /

Technology

design verification / fimndamental scientific technology / radiation / /

URL

www.fda.glov/MedicalDevices/ResourcesforYou/lndustry/default.htm / www.fdat.gov/Medica / /

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