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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K961280
Device Name SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F
Applicant
Scimed Life Systems, Inc.
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact ANGELA RAUN
Correspondent
Scimed Life Systems, Inc.
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact ANGELA RAUN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/03/1996
Decision Date 05/15/1996
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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