510(k) K172468

091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm by Inneuroco, Inc. — Product Code DQY

K172468 is an FDA 510(k) premarket notification submitted by Inneuroco, Inc. for the device "091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm". The FDA issued a decision of Substantially Equivalent on December 6, 2017. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Inneuroco, Inc. has at least 8 other 510(k) clearances on record.