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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K915351
Device Name SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER
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 Number870.1200
Classification Product Code
DQO  
Date Received11/26/1991
Decision Date 06/29/1992
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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