510(k) K060509 ยท NYU Catheter, Hemodialysis, Implanted, Coated
PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING
| Applicant | Tyco Healthcare Group, Mansfield MA, US |
| Decision | Substantially Equivalent, Jun 23, 2006 |
| Received | Feb 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060509
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2008 | Covidien PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- Terminated |
NYU | None listed |
| Dec 4, 2008 | Covidien PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888128461, Size 14.5Fr/Ch (4.85mm) x 28cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- Terminated |
NYU | None listed |
| Dec 4, 2008 | Covidien PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888145069, 14.5 Fr/CH (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Bot Terminated |
NYU | None listed |
| Dec 4, 2008 | Covidien PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed Shaft and Heparin Coating, REF 8888145070, 14.5 FR/CH (4.85mm) x 28 cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: B Terminated |
NYU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.