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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 K920662
Device Name VASCOTWIST 9/60
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 Received02/14/1992
Decision Date 11/24/1993
Decision SE - Postmarket Surveillance Required (SESP)
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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