510(k) Report

Devices descending from K061119

10 later devices reach Enpath Medical Steerable Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122960Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+1K100184Fustar Steerable IntroducersLifetech Scientific (Shenzhen) Co., Ltd.20110—
+1K101784Mobicath BI-Directional Guiding Sheath Model 1000182-XXXGreat Batch Medical201003
+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—