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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 K982077
Device Name SELECTOR DIAGNOSTIC CATHETER
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
5905 nathan ln.
minneapolis,  MN  55442
Contact janell a colley
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/12/1998
Decision Date 08/11/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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