510(k) K102588 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE
| Applicant | Medtronic Ablation Frontiers, LLC, Carlsbad CA, US |
| Decision | Substantially Equivalent, Mar 18, 2011 |
| Received | Sep 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102588
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2015 | Medtronic Inc. Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard Terminated |
DRF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.