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)

INFUSION IV SET

K-Number: K001879 · 2001-11-20

ApplicantNirvi Intl. USA
Decision Date2001-11-20
Product CodeLRS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSION IV SET is the device name listed in this FDA 510(k) record. The listed applicant is Nirvi Intl. USA. It received FDA 510(k) clearance on 2001-11-20 under 510(k) number K001879. The device is classified under product code LRS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFUSION IV SET?

INFUSION IV SET is a medical device that received FDA 510(k) clearance on 2001-11-20. The listed applicant is Nirvi Intl. USA. The 510(k) number is K001879.

When did INFUSION IV SET receive FDA 510(k) clearance?

INFUSION IV SET received FDA 510(k) clearance on 2001-11-20, under 510(k) number K001879.

Who is the listed applicant for INFUSION IV SET?

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

What is the FDA product code for INFUSION IV SET?

The FDA product code for INFUSION IV SET is LRS.

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: LRS)

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.

K050654AMSINO I.V. START KITAmsino International, Inc.K963722IV START KITGrand Medical ProductsK951167EMS I.V. START KITEmergency Medical Supply, Inc.K950184B. BRAUN IV START KITSB. Braun of America, Inc.K944041PERSONAL HEARING SYSTEMResound Corp.K943941SAFESTART VASCULAR ACCESS START KITBecton Dickinson Vascular Access, 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.

↑