510(k) K180904

Sniper Infusion Catheter with Balloon Occlusion by Embolx, Inc. — Product Code MJN

K180904 is an FDA 510(k) premarket notification submitted by Embolx, Inc. for the device "Sniper Infusion Catheter with Balloon Occlusion". The FDA issued a decision of Substantially Equivalent on June 8, 2018. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. Embolx, Inc. has at least 2 other 510(k) clearances on record.