510(k) Report

Devices descending from K003731

113 later devices reach Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation20211Class I
+6K192106AcQRef Introducer SheathAcutus Medical, Inc.20190—
+6K083855Modified Acumen Lead Delivery Sheath with Stylet, Model: Spirit-10.5-59Acumen Medical, Inc.20090—
+7K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC20260—
+7K242106AuST Steerable SheathCenterPoint Systems, LLC20244—
+7K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation20240Class I
+7K220340Amplatzer Steerable Delivery SheathAbbott Medical20222Class I
+8K251051AuST Steerable SheathCenterPoint Systems, LLC20253—
+8K232690Amulet™ Steerable Delivery SheathAbbott Medical20231—
+9K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+9K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+9K250426Amulet™ Steerable Delivery SheathAbbott Medical20250—
+10K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—