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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K882758
Device Name CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
Applicant
3M HEALTH CARE, SARNS
6200 JACKSON RD.
PO BOX 1247
ANN ARBOR,  MI  48106
Applicant Contact JOSEPH W O'DONNELL
Correspondent
3M HEALTH CARE, SARNS
6200 JACKSON RD.
PO BOX 1247
ANN ARBOR,  MI  48106
Correspondent Contact JOSEPH W O'DONNELL
Regulation Number870.4360
Classification Product Code
KFM  
Date Received07/05/1988
Decision Date 10/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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