510(k) Report

Devices descending from K140406

7 later devices reach Destino Twist, Steerable Guiding Sheath through their predicates, nearest generation first.

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