ClearanceBrief
510(k) K121913 ยท OWQ Reprocessed Intravascular Ultrasound Catheter

REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER

ApplicantStryker Sustainability Solutions, Inc., Phoenix AZ, US
DecisionSubstantially Equivalent, Dec 20, 2012
ReceivedJul 2, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K121913

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.