510(k) K243105

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

K243105 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 May 16, 2025. 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 1 other 510(k) clearance on record.