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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K212262
Device Name PCA Syringe Sets
Applicant
Baxter Healthcare Corporation
25212 West Illinois Route 120
Round Lake,  IL  60073
Applicant Contact Jeffrey E. Thompson
Correspondent
Baxter Healthcare Corporation
25212 West Illinois Route 120
Round Lake,  IL  60073
Correspondent Contact Meaghan Bonn
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/20/2021
Decision Date 10/03/2022
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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