510(k) Report

Devices descending from K001139

9 later devices reach Preface Guiding Sheath, Models 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101497Delivery Sheath, Model Adelante BreezewayOscor, Inc.2010830
+2K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+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—