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)

EURO-COLLINS SOLUTION SETS

K-Number: K884609 · 1989-01-26

ApplicantFresenius USA, Inc.
Decision Date1989-01-26
Product CodeKDL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EURO-COLLINS SOLUTION SETS is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius USA, Inc.. It received FDA 510(k) clearance on 1989-01-26 under 510(k) number K884609. The device is classified under product code KDL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EURO-COLLINS SOLUTION SETS?

EURO-COLLINS SOLUTION SETS is a medical device that received FDA 510(k) clearance on 1989-01-26. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K884609.

When did EURO-COLLINS SOLUTION SETS receive FDA 510(k) clearance?

EURO-COLLINS SOLUTION SETS received FDA 510(k) clearance on 1989-01-26, under 510(k) number K884609.

Who is the listed applicant for EURO-COLLINS SOLUTION SETS?

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

What is the FDA product code for EURO-COLLINS SOLUTION SETS?

The FDA product code for EURO-COLLINS SOLUTION SETS is KDL.

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 Fresenius USA, 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.

K992275FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TSK970700FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUXK974584FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TSK973378C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61K9614652008H ON LINE CLEARANCE MONITORK961706P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR

View all 38 devices →

Related Devices (Code: KDL)

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.

K241239OrganProtex HTK SolutionBridge TO Life, Ltd.K221386PERF-GEN Pulsatile Perfusion SolutionInstitut Georges LopezK221387BEL-GEN Cold Storage SolutionInstitut Georges LopezK211842Servator M SALF SolutionS.A.L.F. SpaK192408Custodiol HTK SolutionDr. Franz Kohler Chemie GmbHK170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bagsS.A.L.F. Spa

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.

↑