510(k) K140466 ยท DXO Transducer, Pressure, Catheter Tip
PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300
| Applicant | St. Jude Medical Systems AB, Uppsala, SE |
| Decision | Substantially Equivalent, Nov 13, 2014 |
| Received | Feb 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140466
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.