510(k) Report

Devices descending from K951814

13 later devices reach Triumph-1 Port through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043178Grantalder Rhapsody Access Port and CatheterGrantadler Corportation20064—
+1K032557Triumph VTX with Lifevalve CatheterHorizon Medical Products, Inc.200371
+2K110407InvisiportStealth Therapeutics, Incorporated20111—
+2K082126Rhapsody MriGrantadler Corporation20080—
+2K081889Rhapsody CTGrantadler Corporation20080—
+2K081472Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile…AngioDynamics, Inc.200841
+2K061424Celsite/ Celsite Concept, Access PortsAesculap, Inc.200612
+3K141146InvisiportStealth Therapeutics, Incorporated20150—
+3K130576Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc.201302
+3K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical20112—
+3K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc.20113—
+4K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc.20111—
+5K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc.20200—