510(k) Report

Devices descending from K063377

11 later devices reach Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™…Bard Access Systems, Inc.20251—
+1K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable…Bard Access Systems, Inc.20241—
+1K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG…Bard Peripheral Vascular, Inc.20230—
+1K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc.20190—
+1K133335Powerport Implantable PortC.R. Bard, Inc.20140—
+1K073423Mri Powerport Implanted Port with 9.6 FR Silicone CatheterC.R. Bard, Inc.200713
+1K072549Titanium Powerport Isp Implanted Port with 6 FR Chronoflex Polyurethane CatheterC.R. Bard, Inc.200742
+1K072215Titanium Powerport Isp Implanted PortC.R. Bard, Inc.20072—
+2K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc.20260—
+2K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable…Bard Access Systems, Inc.20250—
+2K122834Polysite Implantable Infusion PortsPerouse Medical20130—