510(k) K081258 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Jan 6, 2009 |
| Received | May 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081258
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.