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FDA 510(k)

RENAL LINK

K-Number: K990953 · 1999-06-18

ApplicantBaxter Healthcare Corp
Decision Date1999-06-18
Product CodeKPF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENAL LINK 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 1999-06-18 under 510(k) number K990953. The device is classified under product code KPF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENAL LINK?

RENAL LINK is a medical device that received FDA 510(k) clearance on 1999-06-18. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K990953.

When did RENAL LINK receive FDA 510(k) clearance?

RENAL LINK received FDA 510(k) clearance on 1999-06-18, under 510(k) number K990953.

Who is the listed applicant for RENAL LINK?

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 RENAL LINK?

The FDA product code for RENAL LINK is KPF.

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Related Devices (Code: KPF)

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.

K061515RENALSOFTBaxter Healthcare CorpK970989CYBERRENCybernius Medical , Ltd.K955762PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAMFresenius USA, Inc.K913515TOTAL CONTAINMENT DEVICEDencoK875121AMICON EQUALINE FLUID BALANCE SYSTEMAmicon, Inc.K874020ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICEAbbott Laboratories

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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