510(k) K130602 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
LASSO NAV DUO LOOP CATHETER
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Aug 14, 2013 |
| Received | Mar 7, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130602
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2015 | Biosense Webster, Inc. LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06.
LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological Terminated |
DRF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.