510(k) Report

Devices descending from K070159

22 later devices reach Prelude Sheath Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140543Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201461
+1K123618Axera 2 Access SystemArstasis, Inc.20135—
+1K103421Arstasis Dilator AdapterArstasis, Inc.20111—
+1K093232Optiseal Enpath Valved Ptfe Peelable IntroducerGreat Batch Medical201001
+1K091006Itg Vascular Access System, Model 300Arstasis, Inc.2010121
+2K173750Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201842
+2K151877MicroTract Access SystemArstasis, Inc.20150—
+2K150257PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20155—
+2K132263Axera 2 Access SystemArstasis, Inc.20134—
+2K100615Arstasis Access SystemArstasis, Inc.2010111
+3K250909Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20250—
+3K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems20222—
+3K140287Axera RX Access SystemArstasis, Inc.20141—
+3K140201Axera 2 Access SystemArstasis, Inc.20141—
+3K102728Arstasis Access SystemArstasis, Inc.2010101
+4K232260Thinline Sheath IntroducerInneuroco, Inc.20231—
+4K140871Axera 2 Access SystemArstasis, Inc.20140—
+4K103143Arstasis One Latchwire Access SystemArstasis, Inc.20119—
+5K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC20260—
+5K113110Axera Access SystemArstasis, Inc.20118—
+6K121521Axera Access SystemArstasis, Inc.20127—
+7K123135Axera 2 Access System Model AXE200Arstasis, Inc.20136—