510(k) K141146

INVISIPORT by Stealth Therapeutics, Incorporated — Product Code LJT

K141146 is an FDA 510(k) premarket notification submitted by Stealth Therapeutics, Incorporated for the device "INVISIPORT". The FDA issued a decision of Substantially Equivalent on May 1, 2015. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Stealth Therapeutics, Incorporated has at least 1 other 510(k) clearance on record.