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)

FLUID ADMINISTRATION SET FA-3160

K-Number: K791020 · 1979-06-27

ApplicantBurron Medical Products, Inc.
Decision Date1979-06-27
Product CodeEYN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLUID ADMINISTRATION SET FA-3160 is the device name listed in this FDA 510(k) record. The listed applicant is Burron Medical Products, Inc.. It received FDA 510(k) clearance on 1979-06-27 under 510(k) number K791020. The device is classified under product code EYN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUID ADMINISTRATION SET FA-3160?

FLUID ADMINISTRATION SET FA-3160 is a medical device that received FDA 510(k) clearance on 1979-06-27. The listed applicant is Burron Medical Products, Inc.. The 510(k) number is K791020.

When did FLUID ADMINISTRATION SET FA-3160 receive FDA 510(k) clearance?

FLUID ADMINISTRATION SET FA-3160 received FDA 510(k) clearance on 1979-06-27, under 510(k) number K791020.

Who is the listed applicant for FLUID ADMINISTRATION SET FA-3160?

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

What is the FDA product code for FLUID ADMINISTRATION SET FA-3160?

The FDA product code for FLUID ADMINISTRATION SET FA-3160 is EYN.

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 Burron Medical Products, 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.

K870403CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTUREK862412INTESTOPLANTK861479CAVAFIX, CENTRAL VENOUS CATHETER KITK860126STIMUPLEX, NERVE STIMULATORK851293IMPLANTOFIXK841428JEJUNOSTOMY SET FOR TUBE FEEDING

View all 41 devices →

Related Devices (Code: EYN)

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.

K944882IRRIGATION TRAYClinical Resources, Inc.K923941IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINEAmerican Healthcare Corp.K923940IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINEAmerican Healthcare Corp.K923938IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATERAmerican Healthcare Corp.K923939IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATERAmerican Healthcare Corp.K900148KIT PAK IRRIGATION TRAYKit Pak, 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.

↑