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)

CUE AMBULATORY VOLUMETRIC INFUSION PUMP

K-Number: K981816 · 1998-12-04

ApplicantBecton Dickinson Curlin, LLC
Decision Date1998-12-04
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CUE AMBULATORY VOLUMETRIC INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Curlin, LLC. It received FDA 510(k) clearance on 1998-12-04 under 510(k) number K981816. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUE AMBULATORY VOLUMETRIC INFUSION PUMP?

CUE AMBULATORY VOLUMETRIC INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1998-12-04. The listed applicant is Becton Dickinson Curlin, LLC. The 510(k) number is K981816.

When did CUE AMBULATORY VOLUMETRIC INFUSION PUMP receive FDA 510(k) clearance?

CUE AMBULATORY VOLUMETRIC INFUSION PUMP received FDA 510(k) clearance on 1998-12-04, under 510(k) number K981816.

Who is the listed applicant for CUE AMBULATORY VOLUMETRIC INFUSION PUMP?

The FDA 510(k) record lists Becton Dickinson Curlin, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUE AMBULATORY VOLUMETRIC INFUSION PUMP?

The FDA product code for CUE AMBULATORY VOLUMETRIC INFUSION PUMP is FRN.

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: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, 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.

↑