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Central venous catheter / Premarket approval / Cardioplegia / Vascular surgery / Cardiology / Intra-aortic balloon pump / Pulmonary artery catheter / Medicine / Catheters / Cardiac surgery


DEC[removed]Edwards Lifescrences LLC Special 510(k) Premarket Notification IntraClude lntra-Aortic Occlusion Catheter
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Document Date: 2012-01-30 00:32:31

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File Size: 140,82 KB

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Company

Radiological Health Enclosure Edwards Lifesciences LLC / Edwards LifeSciences LLC / Page A-2 S Edwards Lifesciences LLC / Edwards Lifescrences LLC / /

Event

FDA Phase / /

IndustryTerm

announcements concerning your device / predicate device / manufacturing practice requirements / cited predicate device / cardioplegia solution / marketed predicate devices / manufacturing practice / Internet address hittp /

Organization

Food and Drug Administration / Division of Small Manufacturers / office of Device Evaluation / office of Compliane / Cardiovascular Devices Office / Division of Cardiovascular Devices / /

Person

Silver Spring / Spencer Walker / Braint D. Zuckerman / /

/

Position

Director Division / M.D. Director Division / /

Product

Federal Food / K1 / DEC-7 / /

ProvinceOrState

Utah / Maryland / /

Technology

radiation / fundamental scientific technology / html / /

URL

www.fda.gov/cdrh/indLustry/suplport/itidex / /

SocialTag