ClearanceBrief
510(k) K180040 · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation Catheter

ApplicantAbbott Vascular, Santa Clara CA, US
DecisionSubstantially Equivalent, Aug 24, 2018
ReceivedJan 5, 2018
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K180040

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.