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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 K925342
Device Name MEDTRONIC INTERVENTIONAL VASCULAR SHERPA GUIDEWIRE
Applicant
Medtronics Interventional Vascular
37a Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact KIRK DALY
Correspondent
Medtronics Interventional Vascular
37a Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact KIRK DALY
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/20/1992
Decision Date 05/06/1993
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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