multiFiltratePRO System
Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology, Urology
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
- 2026-10-19
- Decision code
- SESE
- Country code
- US
- Device name
- multiFiltratePRO System
- Advisory committee
- GU
- Contact
- Amelia Huynh
- K number
- K261203
- State
- MA
- Date received
- 2026-04-13
- Review advisory committee
- GU
- Postal code
- 02451
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- 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