510(k) K123196 ยท MSD Catheter, Hemodialysis, Implanted
PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH
| Applicant | Covidien, Mansfield MA, US |
| Decision | Substantially Equivalent, Jan 31, 2013 |
| Received | Oct 11, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123196
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2025 | Mozarc Medical US LLC Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. Open, Classified |
MSD | None listed |
| May 30, 2025 | Mozarc Medical US LLC Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. Open, Classified |
MSD | None listed |
| May 30, 2025 | Mozarc Medical US LLC Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. Open, Classified |
MSD | None listed |
| May 30, 2025 | Mozarc Medical US LLC Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. Open, Classified |
MSD | None listed |
| May 30, 2025 | Mozarc Medical US LLC MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter. Open, Classified |
MSD | None listed |
| Apr 24, 2024 | Covidien LP Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialy Open, Classified |
MSD | None listed |
| Apr 24, 2024 | Covidien LP Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion Open, Classified |
MSD | None listed |
| Jul 7, 2022 | Covidien Llc Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion. Open, Classified |
MSD | None listed |
| Jul 7, 2022 | Covidien Llc Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion. Open, Classified |
MSD | None listed |
| Jul 7, 2022 | Covidien Llc Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion. Open, Classified |
MSD | None listed |
| Jul 7, 2022 | Covidien Llc Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion. Open, Classified |
MSD | None listed |
| May 28, 2021 | Covidien, LP Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P Open, Classified |
MSD | None listed |
| May 28, 2021 | Covidien, LP Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P Open, Classified |
MSD | None listed |
| May 28, 2021 | Covidien, LP Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P Open, Classified |
MSD | None listed |
| May 28, 2021 | Covidien, LP Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P Open, Classified |
MSD | None listed |
| May 28, 2021 | Covidien, LP Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P Open, Classified |
MSD | None listed |
| Nov 24, 2015 | Covidien LLC Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm
Item Number: 8888145042
The Palindrome chronic catheter is intended for acute and chronic hemodialys Terminated |
NYU | None listed |
| Nov 24, 2015 | Covidien LLC Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm
Item Number: 8888145017P
The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresi Terminated |
NYU | None listed |
| Nov 24, 2015 | Covidien LLC Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm
Item Number: 8888145042P
The Palindrome chronic catheter is intended for acute and chronic h Terminated |
NYU | None listed |
| Nov 24, 2015 | Covidien LLC Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm
Item Number: 8888145046C
The Palindrome chronic catheter is intended for acute and chronic h Terminated |
NYU | None listed |
| Nov 24, 2015 | Covidien LLC Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm
Item Number: 8888145061P
The Palindrome chronic catheter is intended fo 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 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 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 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.