510(k) Report

Devices descending from K780532

3 later devices reach Percutaneous Sheath Introducer Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202330Impella XR Sheath SetAbiomed, Inc.20200—
+1K112554Transradial Artery Access DevicesTeleflexmedical, Inc.201101
+1K021723Sheath Adapter, Model SA-09847Arrow Intl., Inc.200201