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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K943390
Device Name FLEXFINDER GUIDEWIRE
Applicant
Flexmedics
12400 Whitewater Dr., Suite 2040
Minnetonka,  MN  55343
Applicant Contact DEBRA FRITZ
Correspondent
Flexmedics
12400 Whitewater Dr., Suite 2040
Minnetonka,  MN  55343
Correspondent Contact DEBRA FRITZ
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/14/1994
Decision Date 06/27/1995
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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