510(k) K080179 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
REFLEXION HD HIGH-DENSITY MAPPING CATHETER
| Applicant | St Jude Medical, Minnetonka MN, US |
| Decision | Substantially Equivalent, Jan 7, 2009 |
| Received | Jan 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080179
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2011 | Synthes USA (HQ), Inc. 02.122.590, 90mm Spiral Blade, 14mm,
Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System
For fixation of fractures and osteotomies of the proximal and distal femur in ado Terminated |
KTW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.