510(k) K122461 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
RHYTHMIA MAPPING CATHETER
| Applicant | Rhythmia Medical, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Apr 18, 2013 |
| Received | Aug 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122461
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2014 | Boston Scientific Corp IntellaMap Orion High Resolution Mapping Catheter;
Material number: M004RC64S0; Catalog number RC64S;
Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac stru Terminated |
DRF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.