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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 K922410
Device Name SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL
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 Number870.1330
Classification Product Code
DQX  
Date Received05/21/1992
Decision Date 07/23/1992
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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