510(k) K133821 ยท NEY System, Ablation, Microwave And Accessories
EMPRINT ABLATION SYSTEM
| Applicant | Covidien, LLC, Mansfield MA, US |
| Decision | Substantially Equivalent, Apr 28, 2014 |
| Received | Dec 16, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133821
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2017 | Covidien LLC Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1 Open, Classified |
NEY | None listed |
| Aug 7, 2017 | Covidien LLC Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2 Open, Classified |
NEY | None listed |
| Aug 7, 2017 | Covidien LLC Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1 Open, Classified |
NEY | None listed |
| Aug 7, 2017 | Covidien LLC Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2 Open, Classified |
NEY | None listed |
| Aug 7, 2017 | Covidien LLC Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1 Open, Classified |
NEY | None listed |
| Aug 7, 2017 | Covidien LLC Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2 Open, Classified |
NEY | None listed |
| Mar 17, 2016 | Covidien Medical Products (Shanghai) Manufacturing L.L.C. Short Percutaneous Antenna with Thermosphere" Technology
Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. Terminated |
NEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.