FDA 510(k)

PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015

K-Number: K990643 · 1999-12-07

ApplicantAlthin Medical AB an Affiliate of Baxter Intl

Decision Date1999-12-07

Product CodeKDI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 is the device name listed in this FDA 510(k) record. The listed applicant is Althin Medical AB an Affiliate of Baxter Intl. It received FDA 510(k) clearance on 1999-12-07 under 510(k) number K990643. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015?

PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 is a medical device that received FDA 510(k) clearance on 1999-12-07. The listed applicant is Althin Medical AB an Affiliate of Baxter Intl. The 510(k) number is K990643.

When did PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 receive FDA 510(k) clearance?

PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 received FDA 510(k) clearance on 1999-12-07, under 510(k) number K990643.

Who is the listed applicant for PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015?

The FDA 510(k) record lists Althin Medical AB an Affiliate of Baxter Intl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015?

The FDA product code for PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 is KDI.

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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.