510(k) K250292

OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) by Skydance Vascular, Inc. — Product Code FOZ

K250292 is an FDA 510(k) premarket notification submitted by Skydance Vascular, Inc. for the device "OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)". The FDA issued a decision of Substantially Equivalent on May 2, 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. Skydance Vascular, Inc. has at least 2 other 510(k) clearances on record.