Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ruby Intravascular Catheter

K-Number: K243105 · 2025-05-16

ApplicantVenocare, Inc.
Decision Date2025-05-16
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Ruby Intravascular Catheter is a medical device manufactured by Venocare, Inc.. It received FDA 510(k) clearance on 2025-05-16 under approval number K243105. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ruby Intravascular Catheter?

Ruby Intravascular Catheter is a medical device that received FDA 510(k) clearance on 2025-05-16. It is manufactured by Venocare, Inc.. The 510(k) number is K243105.

When was Ruby Intravascular Catheter approved by the FDA?

Ruby Intravascular Catheter received FDA 510(k) clearance on 2025-05-16, under approval number K243105.

What company makes Ruby Intravascular Catheter?

Ruby Intravascular Catheter is manufactured by Venocare, Inc..

What is the FDA product code for Ruby Intravascular Catheter?

The FDA product code for Ruby Intravascular Catheter is FOZ.

Related Clinical Trials

NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT06662500 FORWARD CAD IDE Study RECRUITING NCT07219758 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK) RECRUITING

Other Devices by Venocare, Inc.

K244047Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)

Related Devices (Code: FOZ)

K162894AccuCath Intravascular CatheterC.R. Bard, Inc. K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC K162377PowerGlide Pro Midline CatheterC.R. Bard, Inc. K161866BioFlo Midline CatheterNavilyst Medical, Inc. K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. K160592SUPERCATH 6Togo Medikit Co., Ltd.

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.

↑