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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, For Peritoneal Dialysis, Disposable
510(k) Number K231849
FOIA Releasable 510(k) K231849
Device Name MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
Applicant
Baxter Healthcare
2512 W. Illinois Rte. 120
Round Lake,  IL  60073
Applicant Contact Brad Roynon
Correspondent
Baxter Healthcare
2512 W. Illinois Rte. 120
Round Lake,  IL  60073
Correspondent Contact Brad Roynon
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received06/23/2023
Decision Date 03/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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