Product code KDI— Gastroenterology, Urology
NXSTAGE SYSTEM ONE
- Classification name
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 345
- First cleared
- Most recent
Clearances under product code KDI — page 2
101–200 of 345- K101715 — FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
- K093069 — NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
- K093964 — VENOFER PUMP
- K093902 — MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
- K100334 — DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811
- K091978 — DBB-06 HEMODIALYSIS DELIVERY SYSTEM
- K083460 — DIALOG WITH ADIMEA OPTION
- K093120 — XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170
- K093379 — TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM
- K090682 — EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00
- K083158 — EXALIS, SOFTWARE VERSION 1.15
- K083778 — XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
- K080964 — FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
- K080650 — OMNI-DL SYSTEM
- K081313 — SH14 HEMOCONCENTRATOR
- K082414 — OPTIFLUX F250NR, MODEL 0500325E
- K082515 — ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX
- K080519 — PRISMAFLEX M150 SET
- K072093 — PRISMAFLEX SYSTEM, VERSION 3.20
- K070643 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
- K061519 — MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
- K071854 — AQUADEX FLEXFLOW SYSTEM
- K072232 — GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL
- K071263 — NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
- K071518 — DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS
- K071298 — HF JUNIOR HEMOFILTER
- K070320 — EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01
- K070512 — MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
- K070222 — FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N
- K063183 — PRISMA M10 PRE SET
- K062922 — MODIFICATION TO AQUADEX FLEXFLOW SYSTEM
- K062079 — XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210
- K062090 — PRISMA SYSTEM R03.10A
- K061837 — NXSTAGE CARTRIDGE EXPRESS
- K053539 — MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
- K060195 — GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
- K060008 — AQUADEX FLEXFLOW SYSTEM
- K050952 — HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR
- K051520 — GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
- K050609 — AQUADEX SYSTEM
- K050525 — NXSTAGE SYSTEM ONE
- K050727 — MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS
- K050603 — OLPUR DIALYZER, MODEL HD 190
- K051187 — REXEED SERIES DIALYZERS
- K042938 — GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
- K043244 — FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
- K041005 — GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
- K041726 — HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX
- K041424 — NXSTAGE SYSTEM ONE
- K040696 — MODIFICATION TO NXSTAGE SYSTEM ONE
- K040255 — POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE
- K040489 — AQUADEX SYSTEM 100, MODEL A1100
- K034064 — FRESENIUS ULTRAFLO HPX HEMODIALYZER
- K023874 — SYSTEM 100 ULTRAFILTRATION CATHETER
- K023509 — DBB-05 HEMODIALYSIS DELIVERY SYSTEM
- K032356 — NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS
- K030050 — TORAYSULFONE DIALYZER, BS-L SERIES
- K032431 — PRISMA M60/M100 SETS
- K030099 — BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
- K031378 — FRESENIUS ULTRAFLUX HEMODIALYZER
- K030592 — GAMBRO POLYFLUX, MODEL 140H, 170H, 210H
- K030974 — EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
- K030975 — EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210
- K024124 — SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT
- K023664 — SYNTRA + DIALYZER, MODEL 200
- K013562 — AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE
- K014152 — NXSTAGE CARTRIDGE EXPRESS
- K021615 — BAXTER ACCURA SYSTEM, MODEL 5M5660
- K021732 — DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT
- K023224 — INFUSION CATHETER EXTENSION SET
- K010805 — PRISMA SYSTEM
- K013418 — AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY
- K013733 — SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET
- K020858 — NXSTAGE THERAPY SYSTEM
- K010131 — PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB
- K011269 — LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR
- K011537 — DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS
- K013550 — CLIRANS E-SERIES DIALYZER
- K011221 — PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
- K012510 — MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
- K002512 — TORAYSULFONE DIALYZER
- K010985 — GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L
- K010667 — GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
- K003023 — COBE HC 700 MIDI HEMOCONCENTRATOR
- K000724 — MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300
- K002210 — SYNTRA DIALYZER, MODEL SYNTRA 120, 160
- K003425 — CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
- K001283 — LIFEMATE HEMOFILTRATION SYSTEM
- K003498 — FRESENIUS OPTIFLUX 200A
- K002277 — FRESENIUS OPTIFLUX 200NR
- K994198 — HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L
- K001250 — APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
- K001156 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET
- K001422 — PSN HEMODIALYZER, MODELS PSN 170, PSN 210
- K000028 — RENAFLO II HF 2000 HEMOFILTER
- K994267 — FRESENIUS 2008K
- K992563 — A-22 HEMODIALYZER
- K992564 — AF-180 HEMODIALYZER
- K992566 — AF-150 HEMODIALYZER
- K992573 — AF-220 HEMODIALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.