Atlas FDA

Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set

FDA 510(k) clearance K212216 · decided 2022-04-01

Clearance details

K-number
K212216
Device name
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2021-07-16
Decision date
2022-04-01
Days to decision
259 days
Clearance type
Traditional
Product code
KDI
Device class
2
Regulation number
876.5860
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Deerfield Lake, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Withou recall (Z-1224-2026)VANTIVE US HEALTHCARE LLC2026-02-02
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Withou recall (Z-1225-2026)VANTIVE US HEALTHCARE LLC2026-02-02
Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product recall (Z-0084-2023)Baxter Healthcare Corporation2022-10-12

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