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FDA 510(k)

BAXTER CA DIALYZER

K-Number: K926567 · 1995-01-11

ApplicantBaxter Healthcare Corp
Decision Date1995-01-11
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BAXTER CA DIALYZER 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 1995-01-11 under 510(k) number K926567. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAXTER CA DIALYZER?

BAXTER CA DIALYZER is a medical device that received FDA 510(k) clearance on 1995-01-11. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K926567.

When did BAXTER CA DIALYZER receive FDA 510(k) clearance?

BAXTER CA DIALYZER received FDA 510(k) clearance on 1995-01-11, under 510(k) number K926567.

Who is the listed applicant for BAXTER CA DIALYZER?

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 BAXTER CA DIALYZER?

The FDA product code for BAXTER CA DIALYZER is FJI.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: FJI)

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.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

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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