510(k) Report

Devices descending from K102588

11 later devices reach Achieve Mapping Catheter and Electrical Cable through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153139Achieve ST Mapping Catheter, Catheter Connecting CableMedtronic, Inc.201610—
+2K240972Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)Surgical Instrument Service and Savings, Inc.20240—
+2K193263Reprocessed Achieve Catheter Connecting CableInnovative Health, LLC20201—
+2K162892Achieve Advance Mapping CatheterMedtronic, Inc.20166—
+3K233900Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation20240—
+3K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping…Boston Scientific Corporation20233Class I
+3K221854Reprocesses Umbilical CableInnovative Health, LLC20220—
+3K191880Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology CatheterInnovative Health, LLC20190—
+4K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation202323
+5K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation20260—
+5K250529Globe Introducer (601-01001)Kardium, Inc.20250—