510(k) Report

Devices descending from K130827

13 later devices reach Firmap Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161240Rhythm View Workstation (non-streaming)Abbott Electrophysiology20164—
+1K153093FIRMap CatheterAbbott Electrophysiology20164—
+1K151245Rhythm View Workstation (non-streaming, steaming option)Topera, Inc.20155—
+1K142901RhythmView WorkstationTopera, Inc.20146—
+1K142182Frimap Adapter Connector (Mac)Topera, Inc.201401
+2K171583RhythmView WorkstationAbbott Electrophysiology20173—
+2K163709FIRMap CatheterAbbott Electrophysiology20173—
+3K223666Ablacath™ Mapping CatheterAblacon, Inc.20232—
+3K203084Ablamap SoftwareAblacon, Inc.20212—
+4K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)Cortex, Inc.20261—
+4K230008Ablamap® SystemAblacon, Inc.20231—
+5K261012OptiMap Catheter - 60mm (OPTI-CATH2-60)Cortex, Inc.20260—
+5K251344OptiMap™ SystemBoston Scientific Corporation20250—