510(k) Report

Devices descending from K083451

9 later devices reach Portex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190663Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6PAJUNK GmbH Medizintechnologie20190—
+1K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Intervene Group, Ltd.20171—
+1K143581Arrow Epidural Catheter KitTeleflexmedical, Inc.20151—
+1K110053Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe KitSmiths Medical Asd, Inc.20125—
+2K201031NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc.20200—
+2K172410Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of…Smiths Medical Asd, Inc.201802
+2K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc.20171Class I
+2K161075Arrow Epidural Catheter KitTeleflexmedical, Inc.20160—
+3K211649PCEA Syringe SetBaxter Healthcare Corporation20210—