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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Permanent Pacemaker Electrode
510(k) Number K910528
Device Name BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS
Applicant
Possis Medical, Inc.
2905 Northwest Blvd.
Minneapolis,  MN  55441
Applicant Contact MICHAEL G SCHULTZ
Correspondent
Possis Medical, Inc.
2905 Northwest Blvd.
Minneapolis,  MN  55441
Correspondent Contact MICHAEL G SCHULTZ
Regulation Number870.3680
Classification Product Code
DTB  
Date Received02/08/1991
Decision Date 08/09/1991
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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