510(k) Report

Devices descending from K970229

27 later devices reach Arrow Transseptal Super Arrow-Flex Percutaneous Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171988Performer Guiding SheathCook Incorporated20180—
+1K122958Delivery Sheath, Model Adelante BreezewayOscor, Inc.2012230
+1K083793Steerable Guide CatheterEvalve, Inc.20098—
+1K081341Reinforced Catheter Introducer System (Rcis)Thomas Medical Products, Inc.200813—
+1K043084Premere Delivery Sheath, Model PDSVelocimed, Inc.20059—
+1K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc.200412
+2K210627Breezeway IIOscor, Inc.20211—
+2K161985Steerable Guide CatheterAbbott Vascular20160—
+2K112239Steerable Guide CatheterAbbott Vascular20111—
+2K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc.2010830
+2K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc.20105—
+2K093866Evalve Steerable Guide CatheterEvalve, Inc.20106—
+2K091596Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc.20097—
+2K083269CrossoverThomas Medical Products, Inc.200902
+2K082163Flowmedica Benephit Infusion SystemsFlowmedica, Inc.200806
+3K242756Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090…Pulnovo Medical (Wuxi) Co., Ltd.20240—
+3K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+3K120086Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable…Cardiosolutions20122—
+4K151951Destino ReachOscor, Inc.20156—
+4K140015Cardiosolutions Dexterity Steerable IntroducerCardiosolutions, Inc.20140—
+4K131332Cardiosolutions Percu-Pro Steerable IntroducerCardiosolutions, Inc.20131—
+5K240829AuST Steerable SheathCenterPoint Systems, LLC20245—
+6K242106AuST Steerable SheathCenterPoint Systems, LLC20244—
+7K251051AuST Steerable SheathCenterPoint Systems, LLC20253—
+8K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+8K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+9K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—