510(k) Report

Devices descending from K153139

10 later devices reach Achieve ST Mapping Catheter, Catheter Connecting Cable through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240972Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)Surgical Instrument Service and Savings, Inc.20240—
+1K193263Reprocessed Achieve Catheter Connecting CableInnovative Health, LLC20201—
+1K162892Achieve Advance Mapping CatheterMedtronic, Inc.20166—
+2K233900Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation20240—
+2K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping…Boston Scientific Corporation20233Class I
+2K221854Reprocesses Umbilical CableInnovative Health, LLC20220—
+2K191880Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology CatheterInnovative Health, LLC20190—
+3K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation202323
+4K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation20260—
+4K250529Globe Introducer (601-01001)Kardium, Inc.20250—