510(k) K101345 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Jun 22, 2010 |
| Received | May 13, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101345
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2012 | Biosense Webster, Inc. EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter
Cardiovascular catheter for use in electrophysiological diagnosis and ablation. Terminated |
DRF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.