510(k) Report

Devices descending from K043489

13 later devices reach Enpath Deflectable Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100135GDS-DC12Guided Delivery Systems20100—
+1K090999Biocardia Morph Sheath GuideBiocardia, Inc.200903
+1K061119Enpath Medical Steerable SheathEnpath Medical, Inc.200610—
+2K122960Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+2K100184Fustar Steerable IntroducersLifetech Scientific (Shenzhen) Co., Ltd.20110—
+2K101784Mobicath BI-Directional Guiding Sheath Model 1000182-XXXGreat Batch Medical201003
+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—