FDA.reportPublic FDA data

510(k) K812353

Device
KF-E SERIES OF HOLLOW FIBER DIALYZERS
Applicant
MEDISYSTEMS CORP.
510(k) number
K812353
Product code
FJI  
Decision
Substantially Equivalent (SESE)
Decision date
1981-09-16
Date received
1981-08-19
Regulation
876.5820
Classification name
Dialyzer, Capillary, Hollow Fiber
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FJI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLC2019-08-23
K122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical Corporation2013-12-04
K043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal Products2005-05-27
K010366DISPOSABLE STORAGE CAPMolded Products, Inc.2001-11-28
K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.2001-06-13
K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America2000-12-04
K991908IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERSIdemsa2000-04-17
K992594A-15 HEMODIALYZERAlthin Medical AB1999-09-24
K992565A-18 HEMODIALYZERAlthin Medical AB1999-09-23
K991512ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-XAsahi Medical Co., Ltd.1999-07-29
K990159DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111Dynamic Technology Corp.1999-04-19
K982337CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZERHaidylena Medical Egypt1998-12-29
K981253ULTRACON ULTRAFILTRATORInterpore Intl.1998-12-11
K980658PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234Baxter Healthcare Corp1998-05-19
K971710ULTRACON ULTRAFILTRATORQuantic Biomedical, Inc.1998-02-27

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases