ClearanceBrief
510(k) K183463 ยท DQY Catheter, Percutaneous

AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm

ApplicantStryker, Fremont CA, US
DecisionSubstantially Equivalent, Mar 13, 2019
ReceivedDec 14, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K183463

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.