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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 K010737
Device Name SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924
Applicant
MEDTRONIC CARDIAC SURGICAL PRODUCTS
7611 NORTHLAND DR.
MINNEAPOLIS,  MN  55428
Applicant Contact MARIE HOLM
Correspondent
MEDTRONIC CARDIAC SURGICAL PRODUCTS
7611 NORTHLAND DR.
MINNEAPOLIS,  MN  55428
Correspondent Contact MARIE HOLM
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/12/2001
Decision Date 04/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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