510(k) Report

Devices descending from K970392

25 later devices reach Cordis Avanti+Catheter Sheath Introducer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050962Merit Prelude Sheath IntroducerMerit Medical Systems, Inc.2005241
+2K150932Sheath IntroducerBioteque Corp.20160—
+2K070159Prelude Sheath IntroducerMerit Medical Systems, Inc.2007223
+3K140543Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201461
+3K123618Axera 2 Access SystemArstasis, Inc.20135—
+3K103421Arstasis Dilator AdapterArstasis, Inc.20111—
+3K093232Optiseal Enpath Valved Ptfe Peelable IntroducerGreat Batch Medical201001
+3K091006Itg Vascular Access System, Model 300Arstasis, Inc.2010121
+4K173750Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201842
+4K151877MicroTract Access SystemArstasis, Inc.20150—
+4K150257PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20155—
+4K132263Axera 2 Access SystemArstasis, Inc.20134—
+4K100615Arstasis Access SystemArstasis, Inc.2010111
+5K250909Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20250—
+5K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems20222—
+5K140287Axera RX Access SystemArstasis, Inc.20141—
+5K140201Axera 2 Access SystemArstasis, Inc.20141—
+5K102728Arstasis Access SystemArstasis, Inc.2010101
+6K232260Thinline Sheath IntroducerInneuroco, Inc.20231—
+6K140871Axera 2 Access SystemArstasis, Inc.20140—
+6K103143Arstasis One Latchwire Access SystemArstasis, Inc.20119—
+7K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC20260—
+7K113110Axera Access SystemArstasis, Inc.20118—
+8K121521Axera Access SystemArstasis, Inc.20127—
+9K123135Axera 2 Access System Model AXE200Arstasis, Inc.20136—