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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 K201075
Device Name BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter
Applicant
Becton, Dickinson and Company
9450 South State Street
Sandy,  UT  84070
Applicant Contact Kimberly Geisler
Correspondent
Becton, Dickinson and Company
9450 South State Street
Sandy,  UT  84070
Correspondent Contact Kimberly Geisler
Regulation Number880.5200
Classification Product Code
FOZ  
Subsequent Product Code
DYB  
Date Received04/22/2020
Decision Date 12/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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