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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 K914194
Device Name SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE
Applicant
Scimed Life Systems, Inc.
6655 Wedgwood Rd.
Maple Grove,  MN  55369
Applicant Contact DARLENE A THOMETZ
Correspondent
Scimed Life Systems, Inc.
6655 Wedgwood Rd.
Maple Grove,  MN  55369
Correspondent Contact DARLENE A THOMETZ
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/18/1991
Decision Date 06/09/1992
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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