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Balloon catheter / Cardiogenic shock / Cardiac output / Intra-aortic balloon pump / Pulmonary artery catheter / Medicine / Catheters / Intensive care medicine


KU%(239Z7 FI 4-S3 Cardiac Assist, MAQUET Cardiovascular LLC Premarket Notification Special 510(k) SENSATIONS PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter and Accessories Confidential
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Document Date: 2011-10-31 00:34:16

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File Size: 176,74 KB

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City

Fairfield / /

Company

MAQUET Cardiovascular LLC / /

Currency

pence / USD / /

Event

FDA Phase / /

Facility

Center i'or Devies / Mechanical bridge / /

IndustryTerm

tie device / fiber optic technology / assist devices / predicate devices / cardiac assist device / information oil / fiber-optic pressure sensor technology / marketed predicate devices / fundamental scientific technology / thre device / tquality systems / /

MedicalCondition

Requirements specification review Performance testing Biocompatibility testing Sterility / Refractory Unstable Angina / Post-surgical myocardial dysfunction/low cardiac output syndrome / Septic Shock / Cardiogenic Shock / Acute Myocardial Infarction / /

MedicalTreatment

cardiac surgery / Catheter / Catheters / /

Organization

United Nations / office of Device Evaluation / Division of Postmardket Surveillance / FDA / Cardiovascular Devices Office / Device Evaluation Center for Devices / DEPARTMENT OF HEALTH / Division of Cardiovascular Devices / Division of Simall Maimfacturers / International and Consuimer Assistance / /

Person

Fielder A. Sousa / Zuckermlan / /

/

Position

Manager Phone / GENERAL INFORMATION Submitter / general information oil / Regulatory Affairs Program Manager / Director Division / M.D. Director Division / /

Product

SENSATION TM PLUS 8Fr / Federal Food / /

ProvinceOrState

New Jersey / /

Technology

design verification / radiation / fundamental scientific technology / fiber optic technology / same fiber-optic pressure sensor technology / fiber optic / DSP / /

SocialTag