510(k) K260432

Ruby Intravascular Catheter by Venocare, Inc. — Product Code FOZ

K260432 is an FDA 510(k) premarket notification submitted by Venocare, Inc. for the device "Ruby Intravascular Catheter". The FDA issued a decision of Substantially Equivalent on September 2, 2026. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Venocare, Inc. has at least 2 other 510(k) clearances on record.