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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K992142
Device Name SCIMED ANGIOGRAPHIC CATHETERS
Applicant
Scimed
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact MELANIE RASKA
Correspondent
Scimed
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact MELANIE RASKA
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/24/1999
Decision Date 07/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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