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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 K914312
Device Name SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS
Applicant
Scimed Life Systems, Inc.
6655 Wedgwood Rd.
Maple Grove,  MN  55369
Applicant Contact MERCEDES P BAYANI
Correspondent
Scimed Life Systems, Inc.
6655 Wedgwood Rd.
Maple Grove,  MN  55369
Correspondent Contact MERCEDES P BAYANI
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/26/1991
Decision Date 11/22/1991
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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