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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemodialysis System For Home Use
510(k) Number K242269
Device Name SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
Applicant
Quanta Dialysis Technologies, Ltd.
The Woods, Haywood Rd.
Warwick,  GB CV34 5AH
Applicant Contact Sam Drew
Correspondent
Quanta Dialysis Technologies, Ltd.
The Woods, Haywood Rd.
Warwick,  GB CV34 5AH
Correspondent Contact Chris Rule
Regulation Number876.5860
Classification Product Code
ONW  
Subsequent Product Codes
FJK   KDI  
Date Received08/01/2024
Decision Date 11/01/2024
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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