510(k) K191717

Route 92 Medical Sheath System by Route 92 Medical, Inc. — Product Code DQY

K191717 is an FDA 510(k) premarket notification submitted by Route 92 Medical, Inc. for the device "Route 92 Medical Sheath System". The FDA issued a decision of Substantially Equivalent on January 13, 2020. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Route 92 Medical, Inc. has at least 10 other 510(k) clearances on record.