510(k) Report

Devices descending from K123591

13 later devices reach Flexcath Advance Steerable Sheath (12 French) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping…Boston Scientific Corporation20233Class I
+1K192422Steerable Introducer 12FFreudenberg Medical, LLC20190—
+1K183174FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP20181—
+1K162925AcQGuide Steerable SheathAcutus Medical, Inc.20172—
+1K152310HeartLight Deflectable SheathCardiofocus, Inc.20160—
+1K142684FlexCath Select Steerable Sheath (10 French)Medtronic Cryocath, LP20141Class I
+2K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation202323
+2K211100AcQGuide MAX Steerable SheathAcutus Medical, Inc.20211—
+2K202620FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP20200—
+2K163268FlexCath Select Steerable Shealth and DilatorMedtronic Cryocath, LP20170—
+3K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation20260—
+3K250529Globe Introducer (601-01001)Kardium, Inc.20250—
+3K221044AcQGuide® VUE Steerable SheathAcutus Medical, Inc.20220—