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510(k) K001685

Device
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
Applicant
BAXTER HEALTHCARE CORP.
510(k) number
K001685
Product code
MSE  
Decision
Substantially Equivalent (SESE)
Decision date
2000-11-15
Date received
2000-06-01
Regulation
876.5820
Classification name
Hemodialyzer, Re-use, Low Flux
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
ROBERT L WILKINSON
Address
1620 Waukegan Rd., Mpr-A2e Mcgaw Park IL US 60085 60085

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MSE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K983720ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-Asahi Medical Co., Ltd.1999-05-17
K970700FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUXFresenius USA, Inc.1998-09-15
K97409095 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERSFresenius Medical Care North America1998-08-27
K970654CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)Baxter Healthcare Corp1997-11-12
K970661CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)Baxter Healthcare Corp1997-11-12
K970650ASAHI AM-R SERIES DIALYZERSAsahi Medical Co., Ltd.1997-09-30

Legacy Summary#

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FDA Review#

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