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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Pacemaker, Temporary
510(k) Number K813521
Device Name TRANSLUMINAL BIPOLAR PACING PROBE
Applicant
American Edwards Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Edwards Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3680
Classification Product Code
LDF  
Date Received12/16/1981
Decision Date 03/15/1982
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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