Cleared Traditional

Ruby Intravascular Catheter

K243105 · Venocare, Inc. · General Hospital

May 2025

Decision

228d

Days

Class 2

Risk

About This 510(k) Submission

K243105 is an FDA 510(k) clearance for the Ruby Intravascular Catheter, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Venocare, Inc. (Doral, US). The FDA issued a Cleared decision on May 16, 2025, 228 days after receiving the submission on September 30, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K243105 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	May 16, 2025
Days to Decision	228 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200