510(k) Report

Devices descending from K954595

28 later devices reach Cordis Brite Tip Sheath Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971608Cordis Brite Tip Catheter Sheath Introducer SystemCordis Corp.199711
+1K970392Cordis Avanti+Catheter Sheath Introducer SystemCordis Corp.1997252
+2K050962Merit Prelude Sheath IntroducerMerit Medical Systems, Inc.2005241
+2K974448Cordis Brite Tip Catheter Sheath Introducer SystemCordis Corp.19980—
+3K150932Sheath IntroducerBioteque Corp.20160—
+3K070159Prelude Sheath IntroducerMerit Medical Systems, Inc.2007223
+4K140543Preludeease Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201461
+4K123618Axera 2 Access SystemArstasis, Inc.20135—
+4K103421Arstasis Dilator AdapterArstasis, Inc.20111—
+4K093232Optiseal Enpath Valved Ptfe Peelable IntroducerGreat Batch Medical201001
+4K091006Itg Vascular Access System, Model 300Arstasis, Inc.2010121
+5K173750Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.201842
+5K151877MicroTract Access SystemArstasis, Inc.20150—
+5K150257PreludeEASE Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20155—
+5K132263Axera 2 Access SystemArstasis, Inc.20134—
+5K100615Arstasis Access SystemArstasis, Inc.2010111
+6K250909Prelude Wave Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.20250—
+6K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerMerit Medical Systems20222—
+6K140287Axera RX Access SystemArstasis, Inc.20141—
+6K140201Axera 2 Access SystemArstasis, Inc.20141—
+6K102728Arstasis Access SystemArstasis, Inc.2010101
+7K232260Thinline Sheath IntroducerInneuroco, Inc.20231—
+7K140871Axera 2 Access SystemArstasis, Inc.20140—
+7K103143Arstasis One Latchwire Access SystemArstasis, Inc.20119—
+8K261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…Hartman Medical Group, LLC20260—
+8K113110Axera Access SystemArstasis, Inc.20118—
+9K121521Axera Access SystemArstasis, Inc.20127—
+10K123135Axera 2 Access System Model AXE200Arstasis, Inc.20136—