510(k) Report

Devices descending from K043272

15 later devices reach Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical Tip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111372Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual…Covidien201110Class I
+1K092205Palindrome P Hemodialysis CatheterCovidien Lp, Formerly Registered AS Kendall200911—
+1K060972Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby)Kendall2006738
+1K060509Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin CoatingTyco Healthcare Group200674
+2K182443Pristine Hemodialysis CatheterPristine Access Technologies, Ltd.20192—
+2K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter…Covidien20134Class I
+2K112477Palindrome H, SI, Hsi Chronic CatheterCovidien20115Class I
+2K111817Palindrome RT Chronic CatheterCovidien2011013
+2K06267114.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve…Kendall2006624
+3K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.20211—
+3K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical20143—
+4K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—
+4K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.)20172—
+5K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp)20200—
+5K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm…Medical Components, Inc. (dba MedComp)20181—