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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 K974241
Device Name SCIMED INFORMER PRESSURE WIRE SYSTEM
Applicant
Scimed Life Systems, Inc.
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact JILL TOWNSEND
Correspondent
Scimed Life Systems, Inc.
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact JILL TOWNSEND
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/12/1997
Decision Date 11/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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