510(k) Report

Devices descending from K122431

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132164Heartspan Steerable Introducer KitMerit Medical Systems, Inc.20133—
+2K170668HeartSpan Steerable Sheath IntroducerMerit Medical Systems, Inc.20170—
+2K142684FlexCath Select Steerable Sheath (10 French)Medtronic Cryocath, LP20141Class I
+3K163268FlexCath Select Steerable Shealth and DilatorMedtronic Cryocath, LP20170—