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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
Applicant
Angiomedics, Inc.
2905 Northwest Blvd.
Minneapolis,  MN  55441
Applicant Contact HOWARD B WITTELS
Correspondent
Angiomedics, Inc.
2905 Northwest Blvd.
Minneapolis,  MN  55441
Correspondent Contact HOWARD B WITTELS
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/28/1986
Decision Date 03/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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