510(k) Report

Devices descending from K081341

13 later devices reach Reinforced Catheter Introducer System (Rcis) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122958Delivery Sheath, Model Adelante BreezewayOscor, Inc.2012230
+1K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc.2010830
+1K083269CrossoverThomas Medical Products, Inc.200902
+2K210627Breezeway IIOscor, Inc.20211—
+2K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+3K242756Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090…Pulnovo Medical (Wuxi) Co., Ltd.20240—
+3K151951Destino ReachOscor, Inc.20156—
+4K240829AuST Steerable SheathCenterPoint Systems, LLC20245—
+5K242106AuST Steerable SheathCenterPoint Systems, LLC20244—
+6K251051AuST Steerable SheathCenterPoint Systems, LLC20253—
+7K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+7K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+8K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—