510(k) Report

Devices descending from K150219

6 later devices reach Equashield Closed System drug Transfer Device (CSTD) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd.20175—
+2K221513Equashield Closed System Transfer DeviceEquashield Medical, Ltd.20230—
+2K201460Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd.20223—
+3K241988ProSeal™ Closed System Bag AccessEpic Medical Pte., Ltd.20242—
+4K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte., Ltd.20250—
+4K243976ZeroClear™ Bag Access (423100)Epic Medical Pte., Ltd.20250—