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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 K932420
Device Name SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING
Applicant
Scimed Life Systems, Inc.
6655 Wedgwood Rd.
Maple Grove,  MN  55311
Applicant Contact DAVID A TEICHER
Correspondent
Scimed Life Systems, Inc.
6655 Wedgwood Rd.
Maple Grove,  MN  55311
Correspondent Contact DAVID A TEICHER
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/19/1993
Decision Date 08/17/1993
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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