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)

EPISTAXIS CATHETER/KIT

K-Number: K821584 · 1982-06-14

ApplicantBivona Medical Technologies
Decision Date1982-06-14
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EPISTAXIS CATHETER/KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1982-06-14 under 510(k) number K821584. The device is classified under product code EMX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPISTAXIS CATHETER/KIT?

EPISTAXIS CATHETER/KIT is a medical device that received FDA 510(k) clearance on 1982-06-14. The listed applicant is Bivona Medical Technologies. The 510(k) number is K821584.

When did EPISTAXIS CATHETER/KIT receive FDA 510(k) clearance?

EPISTAXIS CATHETER/KIT received FDA 510(k) clearance on 1982-06-14, under 510(k) number K821584.

Who is the listed applicant for EPISTAXIS CATHETER/KIT?

The FDA 510(k) record lists Bivona Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPISTAXIS CATHETER/KIT?

The FDA product code for EPISTAXIS CATHETER/KIT is EMX.

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 Bivona Medical Technologies 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.

K952700SUPERSLICKK942025BURGET NASAL STENTK944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBESK935053BIVONA NASAL TURBINATE STENTK933398BIVONA ILLUMINATED ENDOTRACHEAL TUBEK931749BIVONA(R) ICU ENDOTRACHEAL TUBE

View all 50 devices →

Related Devices (Code: EMX)

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.

K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLCK041446NASALCEASELes Laboratorires Brothier, S.A.K000108RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100Bhk HoldingK993362HYLASINEBiomatrix, Inc.K983276HYDROFERA BACTERISTATIC NASAL DRESSINGHydrofera, LLCK982731MEROGEL NASAL DRESSING AND SINUS STENTXomed, 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.

↑