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FDA 510(k)

CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)

K-Number: K970663 · 1998-01-11

ApplicantBaxter Healthcare Corp
Decision Date1998-01-11
Product CodeMSF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) 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 1998-01-11 under 510(k) number K970663. The device is classified under product code MSF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)?

CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) is a medical device that received FDA 510(k) clearance on 1998-01-11. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K970663.

When did CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) receive FDA 510(k) clearance?

CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) received FDA 510(k) clearance on 1998-01-11, under 510(k) number K970663.

Who is the listed applicant for CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)?

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 CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)?

The FDA product code for CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) is MSF.

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Related Devices (Code: MSF)

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.

K023615GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LRGambro Renal ProductsK994390GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTERGambro HealthcareK970681ALTRA NOVA 200 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter IntlK970679ALTRA FLUX 200 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter IntlK970662CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)Baxter Healthcare CorpK970653CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)Baxter Healthcare Corp

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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