510(k) Report

Devices descending from K034025

9 later devices reach NMT Medical Transseptal Sheath Set, Models TSS-10-HSC, TSS-11-HSC, TSS12-HSC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083793Steerable Guide CatheterEvalve, Inc.20098—
+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—
+3K120086Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable…Cardiosolutions20122—
+4K140015Cardiosolutions Dexterity Steerable IntroducerCardiosolutions, Inc.20140—
+4K131332Cardiosolutions Percu-Pro Steerable IntroducerCardiosolutions, Inc.20131—