FDA Product Code
FDA Product Code KDI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5860
510(k) Clearances — 345 records · page 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K990643 | PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 | Althin Medical AB an Affiliate of Baxter Intl | 1999-12-07 | Traditional | PDF ↗ |
| K992894 | MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 | Baxter Healthcare Corp | 1999-11-24 | Traditional | PDF ↗ |
| K993064 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) | Gambro Renal Care Products | 1999-10-06 | Special | PDF ↗ |
| K982926 | FRESENIUS BLOOD VOLUME MONITOR | Fresenius Medical Care North America | 1999-09-03 | Traditional | PDF ↗ |
| K992275 | FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS | Fresenius USA, Inc. | 1999-08-04 | Special | PDF ↗ |
| K991520 | FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION | Fresenius Medical Care North America | 1999-07-30 | Traditional | PDF ↗ |
| K982413 | COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS | Gambro Healthcare | 1999-04-21 | Traditional | PDF ↗ |
| K982134 | DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 | Dynamic Technology Corp. | 1999-04-14 | Traditional | PDF ↗ |
| K982414 | GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS | Gambro Healthcare | 1999-03-26 | Traditional | PDF ↗ |
| K980386 | HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) | Gambro Healthcare | 1999-02-24 | Traditional | PDF ↗ |
| K983085 | HEMOCOR HPH 700 HEMOCONCENTRATOR | Minntech Corp. | 1998-11-13 | Traditional | PDF ↗ |
| K973322 | DIAPACT CRRT | B.Braun Medical, Inc. | 1998-11-10 | Traditional | PDF ↗ |
| K982760 | COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET | Gambro Healthcare | 1998-11-04 | Traditional | PDF ↗ |
| K981681 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) | Gambro Healthcare | 1998-08-11 | Traditional | PDF ↗ |
| K974652 | BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER | Baxter Healthcare Corp | 1998-07-10 | Traditional | PDF ↗ |
| K963440 | DIALOG DIALYSIS MACHINE | B. Braun Medical AG | 1998-06-26 | Traditional | PDF ↗ |
| K980656 | PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 | Baxter Healthcare Corp | 1998-05-19 | Traditional | PDF ↗ |
| K974584 | FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS | Fresenius USA, Inc. | 1998-05-14 | Traditional | PDF ↗ |
| K980859 | HEMOCOR HPH MINI HEMOCONCENTRATOR | Minntech Corp. | 1998-05-12 | Traditional | PDF ↗ |
| K973516 | CAPIOX HEMOCONCENTRATOR | Terumo Medical Corp. | 1998-01-30 | Traditional | PDF ↗ |
| K970253 | COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET | Gambro Healthcare | 1997-09-26 | Traditional | PDF ↗ |
| K970591 | BLOOD MONITOR PUMP | Baxter Healthcare Corp | 1997-09-09 | Traditional | PDF ↗ |
| K971180 | BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT | C.R. Bard, Inc. | 1997-07-24 | Traditional | PDF ↗ |
| K970739 | RMI HEMOCONCENTRATOR PREFERENCE PACK | Research Medical, Inc. | 1997-07-08 | Traditional | PDF ↗ |
| K961465 | 2008H ON LINE CLEARANCE MONITOR | Fresenius USA, Inc. | 1997-07-03 | Traditional | PDF ↗ |
| K970446 | DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM | Althin Medical AB an Affiliate of Baxter Intl | 1997-06-02 | Traditional | PDF ↗ |
| K964922 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM | Althin Medical AB an Affiliate of Baxter Intl | 1997-05-21 | Traditional | PDF ↗ |
| K955592 | COBE CENTRYSYSTEM 14 PES HEMODIALYZERS | Cobe Renal Care, Inc. | 1997-04-30 | Traditional | PDF ↗ |
| K955487 | GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS | Cobe Renal Care, Inc. | 1997-04-18 | Traditional | PDF ↗ |
| K963203 | BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT | Baxter Healthcare Corp | 1997-03-25 | Traditional | PDF ↗ |
| K953996 | NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS | NIKKISO CO., LTD. | 1997-03-19 | Traditional | PDF ↗ |
| K946279 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) | Cobe Renal Care, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K955384 | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION | Althin Medical AB an Affiliate of Baxter Intl | 1997-01-10 | Traditional | PDF ↗ |
| K962707 | MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET | Minntech Corp. | 1996-10-09 | Traditional | PDF ↗ |
| K962427 | COBE CENTRYSYSTEM 700 HG HEMODIALYZER | Gambro Healthcare | 1996-09-20 | Traditional | PDF ↗ |
| K960474 | COBE CENTRYSYSTEM 600 HG HEMODIALYZERS | Cobe Renal Care, Inc. | 1996-08-14 | Traditional | PDF ↗ |
| K954987 | ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM | Althin Medical AB an Affiliate of Baxter Intl | 1996-08-08 | Traditional | PDF ↗ |
| K951311 | GAMBRO HC 14R HEMOCONCENTRATOR | Cobe Renal Care, Inc. | 1996-01-11 | Traditional | PDF ↗ |
| K952983 | ALTR NOVA 110 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-10-05 | Traditional | PDF ↗ |
| K952978 | ALTRA FLUX 110 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-10-05 | Traditional | PDF ↗ |
| K952982 | ALTREX 110 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-10-05 | Traditional | PDF ↗ |
| K952342 | GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS | Cobe Renal Care, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K945747 | GAMBRO LUNDIA 94-600 DIALYZER | Cobe Renal Care, Inc. | 1995-09-08 | Traditional | PDF ↗ |
| K951344 | RMI HEMOCONCENTRATOR | Research Medical, Inc. | 1995-08-15 | Traditional | PDF ↗ |
| K942681 | FILTRYZER | Toray Industries (America), Inc. | 1995-06-22 | Traditional | PDF ↗ |
| K945621 | ALTRA NOVA(TM) 170 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-30 | Traditional | PDF ↗ |
| K945625 | ALTRA NOVA(TM) 140 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-30 | Traditional | PDF ↗ |
| K945542 | ALTRA FLUX(TM) 170 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-23 | Traditional | PDF ↗ |
| K945620 | ALTRA FLUX(TM) 140 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-18 | Traditional | PDF ↗ |
| K950522 | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER | Baxter Healthcare Corp | 1995-04-27 | Traditional | PDF ↗ |
| K933883 | GAMBRO FH 66 D HEMOFILTER | Cobe Renal Care, Inc. | 1995-03-13 | Traditional | PDF ↗ |
| K945596 | ALTRES(R) 140 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-03-08 | Traditional | PDF ↗ |
| K945597 | ALTRES(R) 170 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-03-08 | Traditional | PDF ↗ |
| K945595 | ALTREX(R) 200 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-03-08 | Traditional | PDF ↗ |
| K926379 | ALTRA NOVA 200 HEMODAILYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-02-13 | Traditional | PDF ↗ |
| K926373 | ALTRA FLUX 200 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-02-13 | Traditional | PDF ↗ |
| K933818 | GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER | C.G.H. Medical, Inc. | 1995-01-25 | Traditional | PDF ↗ |
| K926568 | BAXTER CT DIALYZER | Baxter Healthcare Corp | 1994-09-30 | Traditional | PDF ↗ |
| K920757 | FILTRAL HEMODIALYZERS | C.G.H. Medical, Inc. | 1994-08-05 | Traditional | PDF ↗ |
| K923727 | PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000 | Minntech Corp. | 1994-07-29 | Traditional | PDF ↗ |
| K931720 | LUNDIA ALPHA 700 HEMODIALYZER | C.G.H. Medical, Inc. | 1994-07-07 | Traditional | PDF ↗ |
| K924437 | HEMOSPAL KIT B22 / MULTIFLOW 60 KIT | C.G.H. Medical, Inc. | 1994-06-27 | Traditional | PDF ↗ |
| K923139 | HEMOCOR HP HEMOCONCENTRATOR SERIES | Minntech Corp. | 1994-02-18 | Traditional | PDF ↗ |
| K923312 | HIGH PERMEABILITY DIALYER | Minntech Corp. | 1994-02-18 | Traditional | PDF ↗ |
| K921134 | FRESENIUS POLYSULFONE DIALYZERS | Fresenius USA, Inc. | 1993-12-02 | Traditional | PDF ↗ |
| K914020 | MODIFIED ASAHI PAN-SERIES HEMOFILTERS | Asahi Medical Co., Ltd. | 1992-03-20 | Traditional | PDF ↗ |
| K914363 | PERITONEAL DIALYSIS CYCLER SET | National Medical Care, Medical Products Div., Inc. | 1992-03-16 | Traditional | PDF ↗ |
| K913950 | DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY | Althin Medical AB an Affiliate of Baxter Intl | 1991-11-01 | Traditional | PDF ↗ |
| K911603 | HEMOSPAL KIT B22 | C.G.H. Medical, Inc. | 1991-08-07 | Traditional | PDF ↗ |
| K911094 | INPERSOL CAPD BIOCAP ADMINISTRATION SET | Abbott Laboratories | 1991-04-16 | Traditional | PDF ↗ |
| K910236 | RENAFLO HDF 1350 HEMODIAFILTER | Minntech Corp. | 1991-04-09 | Traditional | PDF ↗ |
| K903641 | QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q | Bentley Laboratories, Inc. | 1990-11-09 | Traditional | PDF ↗ |
| K902837 | AMICON DIAFILTER 30 HEMOCONCENTRATOR | Amicon, Inc. | 1990-11-01 | Traditional | PDF ↗ |
| K900018 | HOLLOW FIBER DIALYZER, BIO CARE PS 130 | National Medical Care, Medical Products Div., Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K900918 | GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER | Gambro, Inc. | 1990-07-16 | Traditional | PDF ↗ |
| K901286 | AMICON HEMOCONCENTRATOR SET | Amicon, Inc. | 1990-05-18 | Traditional | PDF ↗ |
| K895405 | AMICON MINIFILTER PLUS HEMOFILTER | Amicon, Inc. | 1990-01-11 | Traditional | PDF ↗ |
| K895759 | HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H | National Medical Care, Medical Products Div., Inc. | 1989-11-08 | Traditional | PDF ↗ |
| K893742 | FILTRAL TM 20 HEMODIALYZER/FILTER | Hospal Medical Corp. | 1989-07-24 | Traditional | PDF ↗ |
| K892262 | FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M | Fresenius USA, Inc. | 1989-04-25 | Traditional | PDF ↗ |
| K883407 | TORAY FILTRYZER BK SERIES | Toray Industries (America), Inc. | 1989-02-27 | Traditional | PDF ↗ |
| K890315 | CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G | Baxter Healthcare Corp | 1989-02-08 | Traditional | PDF ↗ |
| K884353 | ULTRX(TM) 850 ARTIFICIAL KIDNEY | Cd Medical, Inc. | 1988-12-08 | Traditional | PDF ↗ |
| K884365 | MULTIFLOW(TM) 60 KIT | Hospal Medical Corp. | 1988-12-08 | Traditional | PDF ↗ |
| K884326 | FILTRAL TM 8 HEMODIALYZER | Hospal Medical Corp. | 1988-12-05 | Traditional | PDF ↗ |
| K883307 | CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT | Hospal Medical Corp. | 1988-10-12 | Traditional | PDF ↗ |
| K883195 | FRESENIUS F8 DIALYZER | Fresenius USA, Inc. | 1988-09-13 | Traditional | PDF ↗ |
| K872767 | FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER | Hospal Medical Corp. | 1987-12-29 | Traditional | PDF ↗ |
| K873887 | MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL. | W.R. Grace & Co.-Conn. | 1987-12-09 | Traditional | PDF ↗ |
| K872456 | HEMOCOR PLUS HEMOCONCENTRATOR | Minntech Corp. | 1987-09-15 | Traditional | PDF ↗ |
| K871108 | GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER | Gambro, Inc. | 1987-05-15 | Traditional | PDF ↗ |
| K870724 | FRESENIUS HEMOFLOW F60 AND F80 | Seratronics, Inc. | 1987-04-01 | Traditional | PDF ↗ |
| K864587 | FRESENIUS ULTRAFLUX AV400, AV600 | Seratronics, Inc. | 1987-03-03 | Traditional | PDF ↗ |
| K863961 | HOSPAL BIOSPAL 1800S | Hospal Medical Corp. | 1986-12-17 | Traditional | PDF ↗ |
| K863823 | AMICON DIAFILTER HEMOFILTER | Amicon, Inc. | 1986-11-06 | Traditional | PDF ↗ |
| K864169 | FRESENIUS HEMOFLOW F50 & F70 | Seratronics, Inc. | 1986-11-06 | Traditional | PDF ↗ |
| K861776 | HIGH EFFICIENCY HEMODIALYSIS SYSTEM | Travenol Laboratories, S.A. | 1986-06-19 | Traditional | PDF ↗ |
| K860938 | GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS | Gambro, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K861106 | FRESENIUS HEMOFLOW F80 DIALYZER | Seratronics, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K855251 | MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS | Advocacy International, Ltd. | 1986-02-04 | Traditional | PDF ↗ |
Product code KDI · Class II · Gastroenterology, Urology. Data: openFDA.