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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 K922706
Device Name SCIMED SIDELINER
Applicant
Scimed
6655 Wedgewood Rd.
Maple Grove,  MN  55369
Applicant Contact MERCEDES P BAYANI
Correspondent
Scimed
6655 Wedgewood Rd.
Maple Grove,  MN  55369
Correspondent Contact MERCEDES P BAYANI
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/05/1992
Decision Date 12/10/1992
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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