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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 K952430
Device Name FINESSE GUIDEWIRE CORONARY
Applicant
Flexmedics
12400 Whitewater Dr., Suite 2040
Minnetonka,  MN  55343
Applicant Contact DEBRA K FRITZ
Correspondent
Flexmedics
12400 Whitewater Dr., Suite 2040
Minnetonka,  MN  55343
Correspondent Contact DEBRA K FRITZ
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/24/1995
Decision Date 08/18/1995
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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