510(k) Report

Devices descending from K050962

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150932Sheath IntroducerBioteque Corp.20160—
+1K070159Prelude Sheath IntroducerMerit Medical Systems, Inc.2007223
+2K140543Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201461
+2K123618Axera 2 Access SystemArstasis, Inc.20135—
+2K103421Arstasis Dilator AdapterArstasis, Inc.20111—
+2K093232Optiseal Enpath Valved Ptfe Peelable IntroducerGreat Batch Medical201001
+2K091006Itg Vascular Access System, Model 300Arstasis, Inc.2010121
+3K173750Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201842
+3K151877MicroTract Access SystemArstasis, Inc.20150—
+3K150257PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20155—
+3K132263Axera 2 Access SystemArstasis, Inc.20134—
+3K100615Arstasis Access SystemArstasis, Inc.2010111
+4K250909Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20250—
+4K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems20222—
+4K140287Axera RX Access SystemArstasis, Inc.20141—
+4K140201Axera 2 Access SystemArstasis, Inc.20141—
+4K102728Arstasis Access SystemArstasis, Inc.2010101
+5K232260Thinline Sheath IntroducerInneuroco, Inc.20231—
+5K140871Axera 2 Access SystemArstasis, Inc.20140—
+5K103143Arstasis One Latchwire Access SystemArstasis, Inc.20119—
+6K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC20260—
+6K113110Axera Access SystemArstasis, Inc.20118—
+7K121521Axera Access SystemArstasis, Inc.20127—
+8K123135Axera 2 Access System Model AXE200Arstasis, Inc.20136—