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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 K992123
Device Name SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
Original Applicant
BOSTON SCIENTIFIC SCIMED, INC.
one sciemd place
maple grove,  MN  55311 -1566
Original Contact melanie raska
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/23/1999
Decision Date 08/23/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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