510(k) Report

Devices descending from K162892

6 later devices reach Achieve Advance Mapping Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233900Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation20240—
+1K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping…Boston Scientific Corporation20233Class I
+1K191880Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology CatheterInnovative Health, LLC20190—
+2K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation202323
+3K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation20260—
+3K250529Globe Introducer (601-01001)Kardium, Inc.20250—