Atlas FDA

CleanCart A, CleanCart C, AK 98 Hemodialysis Machine

FDA 510(k) clearance K232467 · decided 2023-09-14

Clearance details

K-number
K232467
Device name
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2023-08-15
Decision date
2023-09-14
Days to decision
30 days
Clearance type
Special
Product code
KDI
Device class
2
Regulation number
876.5860
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Round Lake, IL, US
Third-party review
No
Expedited review
No

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2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) (K243237)Fresenius Medical Care Renal Therapies Group, LLC2025-06-13
5008X Hemodialysis System (K243505)Fresenius Medical Care Renal Therapies Group, LLC2025-05-30
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (K242155)NIKKISO CO., LTD.2025-05-15
DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) (K243264)Sorin Group Italia S.R.L.2025-04-25

Recalls involving this device

RecordFirmDate
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of Fe recall (Z-0327-2025)Baxter Healthcare Corporation2024-11-13

PMA approvals by this applicant

RecordFirmDate
PerClot® Polysaccharide Hemostatic System (P210036/S008)Baxter Healthcare Corporation2026-08-07
PerClot® Polysaccharide Hemostatic System (P210036/S009)Baxter Healthcare Corporation2026-08-07
PerClot® Polysaccharide Hemostatic System (P210036/S007)Baxter Healthcare Corporation2026-06-08
Preveleak Surgical Sealant (P100030/S021)Baxter Healthcare Corporation2025-07-10
PerClot® Polysaccharide Hemostatic System (P210036/S005)Baxter Healthcare Corporation2025-04-25
Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK (P100030/S020)Baxter Healthcare Corporation2025-04-11
PerClot Polysaccharide Hemostatic System (P210036/S002)Baxter Healthcare Corporation2024-12-20
Seprafilm Adhesion Barrier (P950034/S059)Baxter Healthcare Corporation2024-12-19