510(k) Report

Devices descending from K102176

23 later devices reach Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123591Flexcath Advance Steerable Sheath (12 French)Medtronic Cryocath, LP201213—
+1K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+1K112541Z Flex-270TM Steerable SheathGreat Batch Medical201201
+2K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping…Boston Scientific Corporation20233Class I
+2K192422Steerable Introducer 12FFreudenberg Medical, LLC20190—
+2K183174FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP20181—
+2K162925AcQGuide Steerable SheathAcutus Medical, Inc.20172—
+2K152310HeartLight Deflectable SheathCardiofocus, Inc.20160—
+2K151951Destino ReachOscor, Inc.20156—
+2K142684FlexCath Select Steerable Sheath (10 French)Medtronic Cryocath, LP20141Class I
+3K240829AuST Steerable SheathCenterPoint Systems, LLC20245—
+3K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation202323
+3K211100AcQGuide MAX Steerable SheathAcutus Medical, Inc.20211—
+3K202620FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP20200—
+3K163268FlexCath Select Steerable Shealth and DilatorMedtronic Cryocath, LP20170—
+4K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation20260—
+4K250529Globe Introducer (601-01001)Kardium, Inc.20250—
+4K242106AuST Steerable SheathCenterPoint Systems, LLC20244—
+4K221044AcQGuide® VUE Steerable SheathAcutus Medical, Inc.20220—
+5K251051AuST Steerable SheathCenterPoint Systems, LLC20253—
+6K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+6K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+7K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—