510(k) Report

Devices descending from K982187

10 later devices reach Fast-Cath Intra-Cardiac Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061015Fast-Cath Hemostasis Introducer and Transseptal IntroducerSt Jude Medical20069—
+2K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc.2010830
+3K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+4K151951Destino ReachOscor, Inc.20156—
+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—