510(k) Report

Devices descending from K122958

2 later devices reach Delivery Sheath, Model Adelante Breezeway through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210627Breezeway IIOscor, Inc.20211—
+2K242756Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090…Pulnovo Medical (Wuxi) Co., Ltd.20240—