FDA 510(k)

PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210

K-Number: K001685 · 2000-11-15

Decision Date2000-11-15

Product CodeMSE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2000-11-15 under 510(k) number K001685. The device is classified under product code MSE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210?

PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 is a medical device that received FDA 510(k) clearance on 2000-11-15. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K001685.

When did PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 receive FDA 510(k) clearance?

PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 received FDA 510(k) clearance on 2000-11-15, under 510(k) number K001685.

Who is the listed applicant for PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210?

The FDA product code for PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 is MSE.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: MSE)

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.K970700FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUXFresenius USA, Inc.K97409095 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERSFresenius Medical Care North America K970661CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)Baxter Healthcare Corp K970654CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)Baxter Healthcare Corp K970650ASAHI AM-R SERIES DIALYZERSAsahi Medical Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.