510(k) K031161 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Jul 22, 2003 |
| Received | Apr 14, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031161
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2008 | Biosense Webster Inc Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the Terminated |
DRF | None listed |
| Aug 25, 2008 | Biosense Webster Inc Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the Terminated |
DRF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.