510(k) Report

Devices descending from K963749

7 later devices reach High Pressure Injection Lines through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152387Fluent Inflation DeviceVascular Solutions, Inc.20151—
+1K100576High Pressure Sets-400 PsiIcu Medical, Inc.201008
+1K071196Disposable High Pressure Injection Lines with and Without Rotating AdaptersCoeur, Inc.20072—
+1K023591Ultra High Pressure Injector LinesDeroyal Industries, Inc.20033—
+2K162272Fluent inflation deviceVascular Solutions, Inc.20160—
+2K140356Summed High Pressure LineSunny Medical Device (Shenzhen) Co., Ltd.20150—
+2K131770Pressure Connecting TubeShenzhen Ant Hi-Tech Industrial Co., Ltd.20140—