Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KF-E SERIES OF HOLLOW FIBER DIALYZERS

K-Number: K812353 · 1981-09-16

ApplicantMedisystems Corp.
Decision Date1981-09-16
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KF-E SERIES OF HOLLOW FIBER DIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Medisystems Corp.. It received FDA 510(k) clearance on 1981-09-16 under 510(k) number K812353. 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 KF-E SERIES OF HOLLOW FIBER DIALYZERS?

KF-E SERIES OF HOLLOW FIBER DIALYZERS is a medical device that received FDA 510(k) clearance on 1981-09-16. The listed applicant is Medisystems Corp.. The 510(k) number is K812353.

When did KF-E SERIES OF HOLLOW FIBER DIALYZERS receive FDA 510(k) clearance?

KF-E SERIES OF HOLLOW FIBER DIALYZERS received FDA 510(k) clearance on 1981-09-16, under 510(k) number K812353.

Who is the listed applicant for KF-E SERIES OF HOLLOW FIBER DIALYZERS?

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

What is the FDA product code for KF-E SERIES OF HOLLOW FIBER DIALYZERS?

The FDA product code for KF-E SERIES OF HOLLOW FIBER DIALYZERS is FJI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medisystems Corp. as applicant

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.

K062953MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICEK010279MEDISYSTEMS LUER ACCESS INJECTION SITEK002372ACCESS ALERT GAUGEK994306REVERSOK990803MEDISYSTEMS BUTTONHOLE NEEDLE SETSK983076MEDISYSTEMS TRANSDUCER PROTECTOR

View all 22 devices →

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.

↑