ClearanceBrief
510(k) K062671 ยท MSD Catheter, Hemodialysis, Implanted

14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)

ApplicantKendall, Mansfield MA, US
DecisionUnknown, Nov 3, 2006
ReceivedSep 8, 2006
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K062671

DateFirm and productCodeLinked 510(k)
Jul 1, 2015Covidien LLC
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057C
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145048
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057CP
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048P
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048CP
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049P
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049CP
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050CP
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369P
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409P
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459P
Terminated
MSDNone listed
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509P
Terminated
MSDNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.