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)

ULTRACON ULTRAFILTRATOR

K-Number: K971710 · 1998-02-27

ApplicantQuantic Biomedical, Inc.
Decision Date1998-02-27
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ULTRACON ULTRAFILTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Quantic Biomedical, Inc.. It received FDA 510(k) clearance on 1998-02-27 under 510(k) number K971710. 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 ULTRACON ULTRAFILTRATOR?

ULTRACON ULTRAFILTRATOR is a medical device that received FDA 510(k) clearance on 1998-02-27. The listed applicant is Quantic Biomedical, Inc.. The 510(k) number is K971710.

When did ULTRACON ULTRAFILTRATOR receive FDA 510(k) clearance?

ULTRACON ULTRAFILTRATOR received FDA 510(k) clearance on 1998-02-27, under 510(k) number K971710.

Who is the listed applicant for ULTRACON ULTRAFILTRATOR?

The FDA 510(k) record lists Quantic Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRACON ULTRAFILTRATOR?

The FDA product code for ULTRACON ULTRAFILTRATOR 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

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.

↑