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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, therapeutic, short-term less than 30 days
510(k) Number K220626
Device Name Introcan Safety IV Catheter
B.Braun Medical Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Applicant Contact Tracy Larish
B.Braun Medical Inc.
901 Marcon Blvd.
Allentown,  PA  18109
Correspondent Contact Tracy Larish
Regulation Number880.5200
Classification Product Code
Subsequent Product Code
Date Received03/04/2022
Decision Date 05/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No