510(k) K181051

IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm by Shape Memory Medical — Product Code KRD

K181051 is an FDA 510(k) premarket notification submitted by Shape Memory Medical for the device "IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm". The FDA issued a decision of Substantially Equivalent on Jun 22, 2018. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Shape Memory Medical has 1 other 510(k) clearance on record.