510(k) K202543

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip by Volcano Corporation — Product Code DQX

K202543 is an FDA 510(k) premarket notification submitted by Volcano Corporation for the device "OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip". The FDA issued a decision of Substantially Equivalent on September 28, 2020. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Volcano Corporation has at least 10 other 510(k) clearances on record.