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)

INFUSART

K-Number: K844227 · 1985-01-22

ApplicantSartorius, Inc.
Decision Date1985-01-22
Product CodeFLN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSART is the device name listed in this FDA 510(k) record. The listed applicant is Sartorius, Inc.. It received FDA 510(k) clearance on 1985-01-22 under 510(k) number K844227. 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 INFUSART?

INFUSART is a medical device that received FDA 510(k) clearance on 1985-01-22. The listed applicant is Sartorius, Inc.. The 510(k) number is K844227.

When did INFUSART receive FDA 510(k) clearance?

INFUSART received FDA 510(k) clearance on 1985-01-22, under 510(k) number K844227.

Who is the listed applicant for INFUSART?

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

What is the FDA product code for INFUSART?

The FDA product code for INFUSART 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

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.

↑