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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name introducer, catheter
510(k) Number K022003
Device Name TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305
Original Applicant
2 goodyear
irvine,  CA  92618
Original Contact bill hyatt
Regulation Number870.1340
Classification Product Code
Subsequent Product Code
Date Received06/19/2002
Decision Date 09/13/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No