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)

UMBILI-CATH CATHETER

K-Number: K802414 · 1980-10-23

ApplicantInt'L Corp.
Decision Date1980-10-23
Product CodeFOS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UMBILI-CATH CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Int'L Corp.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K802414. The device is classified under product code FOS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UMBILI-CATH CATHETER?

UMBILI-CATH CATHETER is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Int'L Corp.. The 510(k) number is K802414.

When did UMBILI-CATH CATHETER receive FDA 510(k) clearance?

UMBILI-CATH CATHETER received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802414.

Who is the listed applicant for UMBILI-CATH CATHETER?

The FDA 510(k) record lists Int'L Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UMBILI-CATH CATHETER?

The FDA product code for UMBILI-CATH CATHETER is FOS.

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 Int'L Corp. 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.

K842995EMA LIV CENERA DENTAL CEMENTK842994EMA FREEGENOL DENTAL CEMENTK821814HEMO-NATE L-P KIT

Related Devices (Code: FOS)

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.

K201697Umbilical Vessels CatheterHaolang Medical USA CorporationK130725MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.Covidien Lp, Formerly Registered AS KendallK120304FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETERFootprint Medical, Inc.K091213FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMENFootprint MedicalK091214FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETERFootprint MedicalK081515NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0Neomed, 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.

↑