510(k) Report

Devices descending from K010399

21 later devices reach Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040260Integral Hemodialysis CatheterArrow Int'L.2004515
+1K040078Cannon II PlusArrow International, Inc.20041319
+1K020430Diatek Connector Assembly Replacement Kit (Cark)Diatek, Inc.200212
+2K141051Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis…Arrow International, Inc.20140Class I
+2K102238Arrow (R) Nextstep TM Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc.201131
+2K092205Palindrome P Hemodialysis CatheterCovidien Lp, Formerly Registered AS Kendall200911—
+2K061661Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc.20060—
+2K040666Step-Tip Chronic Hemodialysis CatheterArrow International, Inc.20040—
+3K111817Palindrome RT Chronic CatheterCovidien2011013
+3K111900Nextstep Antegrade Chronic Hemodialysis CatheterTeleflexmedical, Inc.20112Class I
+3K111372Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual…Covidien201110Class I
+4K182443Pristine Hemodialysis CatheterPristine Access Technologies, Ltd.20192—
+4K130192Nextstep RetrogradeArrow International, Inc.20131—
+4K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter…Covidien20134Class I
+4K112477Palindrome H, SI, Hsi Chronic CatheterCovidien20115Class I
+5K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.20211—
+5K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical20143—
+6K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—
+6K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.)20172—
+7K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp)20200—
+7K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm…Medical Components, Inc. (dba MedComp)20181—