510(k) Report

Devices descending from K002054

11 later devices reach X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083793Steerable Guide CatheterEvalve, Inc.20098—
+1K012489Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator)…Appriva Medical, Inc.200110—
+2K161985Steerable Guide CatheterAbbott Vascular20160—
+2K112239Steerable Guide CatheterAbbott Vascular20111—
+2K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc.20105—
+2K093866Evalve Steerable Guide CatheterEvalve, Inc.20106—
+2K091596Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc.20097—
+2K043084Premere Delivery Sheath, Model PDSVelocimed, Inc.20059—
+3K120086Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable…Cardiosolutions20122—
+4K140015Cardiosolutions Dexterity Steerable IntroducerCardiosolutions, Inc.20140—
+4K131332Cardiosolutions Percu-Pro Steerable IntroducerCardiosolutions, Inc.20131—