510(k) K183463

AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm by Stryker — Product Code DQY

K183463 is an FDA 510(k) premarket notification submitted by Stryker for the device "AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm". The FDA issued a decision of Substantially Equivalent on Mar 13, 2019. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Stryker has 270 other 510(k) clearances on record.