510(k) Report

Devices descending from K101497

8 later devices reach Delivery Sheath, Model Adelante Breezeway through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+2K151951Destino ReachOscor, Inc.20156—
+3K240829AuST Steerable SheathCenterPoint Systems, LLC20245—
+4K242106AuST Steerable SheathCenterPoint Systems, LLC20244—
+5K251051AuST Steerable SheathCenterPoint Systems, LLC20253—
+6K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+6K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+7K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—