510(k) Report

Devices descending from K070357

26 later devices reach Flexcath Steerable Sheath & Dilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081049Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12Cryocath Technologies, Inc.200825—
+2K122960Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+2K102176Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model…Medtronic Cryocath, LP2010231
+3K151951Destino ReachOscor, Inc.20156—
+3K123591Flexcath Advance Steerable Sheath (12 French)Medtronic Cryocath, LP201213—
+3K120459Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc.20127—
+3K112541Z Flex-270TM Steerable SheathGreat Batch Medical201201
+4K240829AuST Steerable SheathCenterPoint Systems, LLC20245—
+4K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping…Boston Scientific Corporation20233Class I
+4K192422Steerable Introducer 12FFreudenberg Medical, LLC20190—
+4K183174FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP20181—
+4K162925AcQGuide Steerable SheathAcutus Medical, Inc.20172—
+4K152310HeartLight Deflectable SheathCardiofocus, Inc.20160—
+4K142684FlexCath Select Steerable Sheath (10 French)Medtronic Cryocath, LP20141Class I
+5K242106AuST Steerable SheathCenterPoint Systems, LLC20244—
+5K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation202323
+5K211100AcQGuide MAX Steerable SheathAcutus Medical, Inc.20211—
+5K202620FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP20200—
+5K163268FlexCath Select Steerable Shealth and DilatorMedtronic Cryocath, LP20170—
+6K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation20260—
+6K250529Globe Introducer (601-01001)Kardium, Inc.20250—
+6K251051AuST Steerable SheathCenterPoint Systems, LLC20253—
+6K221044AcQGuide® VUE Steerable SheathAcutus Medical, Inc.20220—
+7K260942AuST Steerable SheathCenterPoint Systems, LLC20261—
+7K260163AuST CSP IntroducerCenterPoint Systems, LLC20260—
+8K261492FieldFlex Steerable SheathCenterPoint Systems, LLC20260—