510(k) Report

Devices descending from K081049

25 later devices reach Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122960Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+1K102176Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model…Medtronic Cryocath, LP2010231
+2K151951Destino ReachOscor, Inc.20156—
+2K123591Flexcath Advance Steerable Sheath (12 French)Medtronic Cryocath, LP201213—
+2K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+2K112541Z Flex-270TM Steerable SheathGreat Batch Medical201201
+3K240829AuST Steerable SheathCenterPoint Systems, LLC20245—
+3K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping…Boston Scientific Corporation20233Class I
+3K192422Steerable Introducer 12FFreudenberg Medical, LLC20190—
+3K183174FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP20181—
+3K162925AcQGuide Steerable SheathAcutus Medical, Inc.20172—
+3K152310HeartLight Deflectable SheathCardiofocus, Inc.20160—
+3K142684FlexCath Select Steerable Sheath (10 French)Medtronic Cryocath, LP20141Class I
+4K242106AuST Steerable SheathCenterPoint Systems, LLC20244—
+4K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation202323
+4K211100AcQGuide MAX Steerable SheathAcutus Medical, Inc.20211—
+4K202620FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP20200—
+4K163268FlexCath Select Steerable Shealth and DilatorMedtronic Cryocath, LP20170—
+5K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation20260—
+5K250529Globe Introducer (601-01001)Kardium, Inc.20250—
+5K251051AuST Steerable SheathCenterPoint Systems, LLC20253—
+5K221044AcQGuide® VUE Steerable SheathAcutus Medical, Inc.20220—
+6K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+6K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+7K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—