510(k) Report

Devices descending from K012854

8 later devices reach Renal Guiding Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081045Destination Renal Guiding SheathTerumo Medical Corp.20085—
+1K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc.200412
+2K172995Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…Terumo Medical Corporation20170—
+2K140641Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, LimaBoston Scientific Corporation20140—
+2K122958Delivery Sheath, Model Adelante BreezewayOscor, Inc.2012230
+2K082163Flowmedica Benephit Infusion SystemsFlowmedica, Inc.200806
+3K210627Breezeway IIOscor, Inc.20211—
+4K242756Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090…Pulnovo Medical (Wuxi) Co., Ltd.20240—