510(k) K112477 ยท NYU Catheter, Hemodialysis, Implanted, Coated
PALINDROME H, SI, HSI CHRONIC CATHETER
| Applicant | Covidien, Mansfield MA, US |
| Decision | Unknown, Sep 28, 2011 |
| Received | Aug 29, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112477
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2022 | Covidien Llc Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion. Open, Classified |
MSD | None listed |
| Jul 7, 2022 | Covidien Llc Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion. Open, Classified |
MSD | None listed |
| Jul 7, 2022 | Covidien Llc Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion. Open, Classified |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm
Item Code: 8888245062
The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm
Item Code: 8888245063 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm
Item Code: 8888245064 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm
Item Code: 8888245064 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm
Item Code: 8888245064 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm
Item Code: 8888223408 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm
Item Code:8888228458 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm
Item Code: 8888233508 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet
14.5 Fr x 19cm
Item Code: 8888145062 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet
14.5 Fr x 19cm
Item Code: 8888145062C Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888145063 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888145063C Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code:8888145064 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888145064C Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888145065 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888145065C Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm
Item Code: 8888145066 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm
Item Code: 8888145066C Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm
Item Code: 8888145062P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm
Item Code: 8888145062CP Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888145063P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888145063CP Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888145064P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888145064CP Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888145065P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 8888145065CP Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm
Item Code: 8888146144P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm
Item Code: 8888146144CP Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm
Item Code: 8888145066P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm
Item Code: 8888145066CP Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm
Item Code: 8888145066CP Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888123408 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888128458 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888128458 Terminated |
NYU | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm
Item Code: 8888119368P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888123408P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888128458P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888133508P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888133508P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm
Item Code: 8888145057C Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm
Item Code: 8888145048 Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888145048C Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888145049 Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code:8888145049C Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888145050 Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888145050C Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888145050C Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm
Item Code: 8888145057CP Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888145048P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888145048CP Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888145049P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888145049CP Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888145050P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888145050CP Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm
Item Code: 8888119369 Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888123409 Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888128459 Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888133509 Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm
Item Code: 8888119369P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888123409P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888128459P Terminated |
MSD | None listed |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888133509P Terminated |
MSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.