510(k) K010838

FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008 by Jomed AG — Product Code DQY

K010838 is an FDA 510(k) premarket notification submitted by Jomed AG for the device "FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008". The FDA issued a decision of Substantially Equivalent on June 21, 2001. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Jomed AG has at least 8 other 510(k) clearances on record.