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)

480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE

K-Number: K880459 · 1988-04-13

ApplicantCd Medical, Inc.
Decision Date1988-04-13
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE is the device name listed in this FDA 510(k) record. The listed applicant is Cd Medical, Inc.. It received FDA 510(k) clearance on 1988-04-13 under 510(k) number K880459. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE?

480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE is a medical device that received FDA 510(k) clearance on 1988-04-13. The listed applicant is Cd Medical, Inc.. The 510(k) number is K880459.

When did 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE receive FDA 510(k) clearance?

480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE received FDA 510(k) clearance on 1988-04-13, under 510(k) number K880459.

Who is the listed applicant for 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE?

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

What is the FDA product code for 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE?

The FDA product code for 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE is FKP.

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 Cd Medical, Inc. 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.

K925654CD HOME DIALYSERVICE HEMODIALYSIS TRAYK910215DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTK901520WURTZ CHOLEY CLIP (TM)K894106DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYSTK884353ULTRX(TM) 850 ARTIFICIAL KIDNEYK8732798810 PUMP-PUMP SINGLE NEEDLE DEVICE

View all 11 devices →

Related Devices (Code: FKP)

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.

K181991NxStage Connected Health SystemNxstage Medical, Inc.K131739NXSTAGE CONNECTED HEALTH SYSTEMNxstage Medical, Inc.K130460NXSTAGE DOSING CALCULATORNxstage Medical, Inc.K040074ONEVIEW INTERFACENxstage Medical, Inc.K021060FRESENIUS ICARE MONITORING SYSTEMFresenius Medical Care North AmericaK003615STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPSEnvironmental Test Systems, Inc.

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.

↑