510(k) Report

Devices descending from K965178

6 later devices reach Niagara Dual Lumen Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090102Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis CathetersC.R. Bard, Inc.20091Class I
+1K030268Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen CathetersC.R. Bard, Inc.20030Class I
+1K012193Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc.20022—
+2K102833Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd.20110—
+2K022688Versabond AB Bone CementSmith & Nephew, Inc.200401
+2K022676Orthoguard AB Antimicrobial SleeveSmith & Nephew, Inc.20020—