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FDA 510(k)

XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210

K-Number: K062079 · 2006-10-19

ApplicantBaxter Healthcare Corporation
Decision Date2006-10-19
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2006-10-19 under 510(k) number K062079. 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 XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210?

XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 is a medical device that received FDA 510(k) clearance on 2006-10-19. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K062079.

When did XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 receive FDA 510(k) clearance?

XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 received FDA 510(k) clearance on 2006-10-19, under 510(k) number K062079.

Who is the listed applicant for XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210?

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

What is the FDA product code for XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210?

The FDA product code for XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 is KDI.

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Related Devices (Code: KDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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