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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K863342
Device Name SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER
Original Applicant
ANGIOMEDICS, INC.
2905 northwest blvd.
minneapolis,  MN  55441
Original Contact howard b wittels
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/28/1986
Decision Date 03/03/1987
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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