510(k) Report

Devices descending from K223824

3 later devices reach POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation202323
+2K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation20260—
+2K250529Globe Introducer (601-01001)Kardium, Inc.20250—