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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 K942927
Device Name 0.035 IN. WISE WIRE
Original Applicant
480 pleasant st.
watertown,  MA  02472 2407
Original Contact christine m harris
Regulation Number870.1200
Classification Product Code
Date Received06/22/1994
Decision Date 06/13/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No