510(k) Report

Devices descending from K081045

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172995Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…Terumo Medical Corporation20170—
+1K140641Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, LimaBoston Scientific Corporation20140—
+1K122958Delivery Sheath, Model Adelante BreezewayOscor, Inc.2012230
+2K210627Breezeway IIOscor, Inc.20211—
+3K242756Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090…Pulnovo Medical (Wuxi) Co., Ltd.20240—