510(k) K151363

Zephyr Vascular Compression Device by Advanced Vascular Dynamics — Product Code DXC

K151363 is an FDA 510(k) premarket notification submitted by Advanced Vascular Dynamics for the device "Zephyr Vascular Compression Device". The FDA issued a decision of Substantially Equivalent on July 31, 2015. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Advanced Vascular Dynamics has at least 7 other 510(k) clearances on record.