510(k) Report

Devices descending from K981909

4 later devices reach Baxter Hemostasis Valve Introducers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131627Catheter Introducer SheathEdwards Lifesciences, LLC20140—
+1K121185Edwards Percutaneous Sheath IntroducerEdwards Lifesciences, LLC20121—
+1K032962AC 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial SurfaceArrow Intl., Inc.20030—
+2K133296XCATHAlseal20140—