FDA.reportPublic FDA data

510(k) K926567

Device
BAXTER CA DIALYZER
Applicant
Baxter Healthcare Corp
510(k) number
K926567
Product code
FJI
Decision
Substantially Equivalent (SESE)
Decision date
1995-01-11
Date received
1992-12-31
Regulation
876.5820
Classification name
Dialyzer, Capillary, Hollow Fiber
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
AMY STUEBER
Address
1500 Waukegan Rd. Waukegan IL US 60085 60085

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K970708CLIRANS T-SERIES HOLLOW FIBER DIALYZERSTerumo Medical Corp.1997-12-19