510(k) Report

Devices descending from K132164

3 later devices reach Heartspan Steerable Introducer Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170668HeartSpan Steerable Sheath IntroducerMerit Medical Systems, Inc.20170—
+1K142684FlexCath Select Steerable Sheath (10 French)Medtronic Cryocath, LP20141Class I
+2K163268FlexCath Select Steerable Shealth and DilatorMedtronic Cryocath, LP20170—