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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 K914121
Device Name VASCOSCREW 6/60 AND VASCOSCREW 8/60
Applicant
Vascor Medical Corp.
P.O. Box 148
Tarpon Springs,  FL  34688
Applicant Contact AUDREY MACCIA
Correspondent
Vascor Medical Corp.
P.O. Box 148
Tarpon Springs,  FL  34688
Correspondent Contact AUDREY MACCIA
Regulation Number870.3680
Classification Product Code
DTB  
Date Received09/13/1991
Decision Date 08/24/1993
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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