510(k) Report

Devices descending from K012489

10 later devices reach Modification to: X-Sept Transseptal Shealth and Transition Catheter (with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043084Premere Delivery Sheath, Model PDSVelocimed, Inc.20059—
+2K083793Steerable Guide CatheterEvalve, Inc.20098—
+3K161985Steerable Guide CatheterAbbott Vascular20160—
+3K112239Steerable Guide CatheterAbbott Vascular20111—
+3K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc.20105—
+3K093866Evalve Steerable Guide CatheterEvalve, Inc.20106—
+3K091596Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc.20097—
+4K120086Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable…Cardiosolutions20122—
+5K140015Cardiosolutions Dexterity Steerable IntroducerCardiosolutions, Inc.20140—
+5K131332Cardiosolutions Percu-Pro Steerable IntroducerCardiosolutions, Inc.20131—