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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 K253235
Device Name Introcan Safety® Deep Access XL IV Catheter
Applicant
B.Braun Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Applicant Contact Tracy Larish
Correspondent
B.Braun Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Correspondent Contact Tracy Larish
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/29/2025
Decision Date 05/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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