510(k) clearances

FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)

Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology, Urology

K243874Substantially EquivalentTraditionalKDI
Open FDA's page for this record
Third party flag
N
City
Waltham
Advisory committee description
Gastroenterology, Urology
Address 1
920 Winter St.
Statement or summary
Summary
Product code
KDI
Zip code
02451
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
Decision date
2025-02-28
Decision code
SESE
Country code
US
Advisory committee
GU
Contact
Timothy Groves
K number
K243874
State
MA
Date received
2024-12-17
Review advisory committee
GU
Postal code
02451
Decision description
Substantially Equivalent
Clearance type
Traditional
Device name

FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)

Harmonized identifiers (openFDA)
Device name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Medical specialty description
Gastroenterology, Urology
Regulation number
876.5860
Device class
2
Registration number
3009128476, 3014479313, 3003589956, 3010377171, 3005695808, 1056186, 3021632375, 3014272786, 1000286794, 9615942, 3004111573, 3043226252, 3003337893, 3004201412, 9680579, 3012149633, 3013764800, 3035708507, 3027592507, 3010355846, 9610825, 3008307705, 3016678045, 1713747, 8010182, 3016096143, 3000247873, 3040314808, 3020689844, 3015335038, 3015136750, 3002879653, 3014300273, 9611824, 3006755813, 3004176176, 3038138522, 3033903155, 1721676, 3003661577 +48 more
FEI number
3009128476, 3014479313, 3003589956, 3010377171, 3002807196, 3005695808, 3021632375, 3014272786, 1000286794, 3004111573, 3043226252, 3003337893, 3004201412, 3002924544, 3012149633, 3013764800, 3035708507, 3027592507, 3010355846, 3008307705, 3016678045, 1713747, 3016096143, 3000247873, 3040314808, 3020689844, 3012394756, 1000191953, 6898, 3015335038, 3015136750, 3003058448, 3005426550, 3002879653, 3014300273, 3006755813, 3004176176, 3002974635, 3002807710, 3001451489 +48 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.