510(k) Report

Devices descending from K081394

3 later devices reach Ptfe Interlock Peelable Introducers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093023Ptfe Peelable IntroducerGreat Batch Medical20092—
+2K102540Ptfe Portable IntroducerGreat Batch Medical20101—
+3K123974Percutaneous Introducer KitTeleflex, Inc.20130—