510(k) K043254

PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH by Onset Medical Corporation — Product Code EZN

K043254 is an FDA 510(k) premarket notification submitted by Onset Medical Corporation for the device "PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH". The FDA issued a decision of Substantially Equivalent on February 10, 2005. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Onset Medical Corporation has at least 7 other 510(k) clearances on record.