510(k) Report

Devices descending from K003245

8 later devices reach Heparin Lock Flush Syring 10 Usp Units/ML, Heparin Lock Flush Syringe, 100 Usp… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032417Heparin Lock Flush SyringeAm2 Pat, Inc.200301
+1K011967BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp SyringeBd20023—
+1K013556Monoject Prefill Heparin Lock Flush SyringeTyco Healthcare20015—
+2K090680Heparin Lock Flush Solution, Usp BD Posiflush Heparin Lock Flush SyringeBecton, Dickinson & CO20091—
+2K032438Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill…Tyco Healthcare20042Class I
+3K163591BD PosiFlush Heparin Lock Flush SyringeBecton, Dickinson and Company20170—
+3K090882Flush Syringe Filled with 0.9% Sodium ChlorideHospira, Inc.201003
+3K060339Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for Sterile DeliveryTyco Healthcare/Kendall2006011