510(k) K113213 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Dec 5, 2011 |
| Received | Nov 1, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113213
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2013 | Biosense Webster, Inc. 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S.
Designed to facilitate electrophysiological mapping of the atria of the heart. Terminated |
DRF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.