510(k) K213531

TR BAND Radial Compression Device by Terumo Medical Corporation — Product Code DXC

K213531 is an FDA 510(k) premarket notification submitted by Terumo Medical Corporation for the device "TR BAND Radial Compression Device". The FDA issued a decision of Substantially Equivalent on December 20, 2021. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Terumo Medical Corporation has at least 10 other 510(k) clearances on record.