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)

GUARDIAN II I.V. CONTROLLER

K-Number: K790836 · 1979-07-30

ApplicantCentaur Sciences, Inc.
Decision Date1979-07-30
Product CodeFLN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GUARDIAN II I.V. CONTROLLER is the device name listed in this FDA 510(k) record. The listed applicant is Centaur Sciences, Inc.. It received FDA 510(k) clearance on 1979-07-30 under 510(k) number K790836. The device is classified under product code FLN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUARDIAN II I.V. CONTROLLER?

GUARDIAN II I.V. CONTROLLER is a medical device that received FDA 510(k) clearance on 1979-07-30. The listed applicant is Centaur Sciences, Inc.. The 510(k) number is K790836.

When did GUARDIAN II I.V. CONTROLLER receive FDA 510(k) clearance?

GUARDIAN II I.V. CONTROLLER received FDA 510(k) clearance on 1979-07-30, under 510(k) number K790836.

Who is the listed applicant for GUARDIAN II I.V. CONTROLLER?

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

What is the FDA product code for GUARDIAN II I.V. CONTROLLER?

The FDA product code for GUARDIAN II I.V. CONTROLLER is FLN.

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 Centaur Sciences, 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.

K830258CENTAURSET 300 & 300 P.E.D

Related Devices (Code: FLN)

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.

K172242DripAssist PlusShift Labs, Inc.K080704LOW FLUID ALARMEm-Tec GmbHK050783ISSYS DRUG FLOW MONITORIntegrated Sensing Systems, Inc.K060123LEVELERT II FLUID LEVEL SENSORSmith & Nephew, Inc.K030136DRIP ALERTDrip Alert, Inc.K022248STRYKER L3 HYDROLERTStryker Endoscopy

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.

↑