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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 K780953
Device Name MODEL 1861 BLOOD PUMP
Applicant
MEDTRONIC VASCULAR
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDTRONIC VASCULAR
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.4360
Classification Product Code
KFM  
Date Received06/09/1978
Decision Date 08/31/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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