510(k) Report

Devices descending from K024065

2 later devices reach Soft Venous Reservoir (Svrxx) with GBS Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082082Gish SVR Soft Venous Reservoirs with HA CoatingGish Biomedical, Inc.20090—
+1K050195V-Bag with GBS CoatingGish Biomedical, Inc.20050—