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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 K961499
Device Name LAGUNA "SOFTIP" DIAGNOSTIC CATHETERS
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
5905 nathan ln.
minneapolis,  MN  55442
Contact maria brittle
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/18/1996
Decision Date 10/17/1996
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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