510(k) K232190

6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter by Medtronic Vascular — Product Code DQY

K232190 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter". The FDA issued a decision of Substantially Equivalent on August 22, 2023. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Medtronic Vascular has at least 10 other 510(k) clearances on record.