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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 K252137
Device Name BD Insyte™ IV Catheter
Applicant
Becton Dickinson Infusion Therapy Systems, Inc.
9450 S. State St.
Sandy,  UT  84070
Applicant Contact Teresa Do-McCage
Correspondent
Becton Dickinson Infusion Therapy Systems, Inc.
9450 S. State St.
Sandy,  UT  84070
Correspondent Contact Rupali Gupta
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/08/2025
Decision Date 04/02/2026
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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