AtriCure, Inc.
FDA 510(k) medical device clearances.
Top product codes for AtriCure, Inc.
Recent clearances by AtriCure, Inc.
- K252056 — Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)
- K250371 — cryoICE cryoXT cryoablation probe (cryoXT)
- K243860 — AtriClip PRO-Mini LAA Exclusion System (PROM)
- K243157 — AtriCure cryoICE BOX (ACM)
- K234151 — Isolator Synergy EnCapture Ablation System (EMH)
- K234125 — AtriClip FLEX-Mini LAA Exclusion System (ACHM)
- K233959 — EPi-Ease Epicardial Access Device (EAS)
- K233407 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)
- K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
- K221358 — Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)
- K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
- K211311 — AtriCure Isolator® Synergy Surgical Ablation System
- K210293 — AtriClip LAA Exclusion System
- K200697 — AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
- K193162 — EPi-Sense Guided Coagulation System with VisiTrax
- K192125 — Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
- K191413 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip
- K190587 — Coolrail Linear Pen
- K190151 — COBRA Fusion Ablation System
- K183065 — Coolrail Linear Pen
- K182565 — AtriCure cryoICE cryoSPHERE cryoablation probe
- K181474 — ArtiClip LAA Exclusion System
- K180137 — AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
- K180138 — AtriCure cryoICE cryo-ablation probe (CRYO2)
- K180010 — AtriClip FLEX-V
- K173031 — AtriClip LAA Exclusion System with Preloaded PRO·V Clip
- K172742 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
- K163261 — AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
- K163408 — Isolator Multifunctional Linear Pen
- K152337 — cryoFORM cryoICE cryoablation probe
- K160454 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
- K153500 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip
- K150996 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
- K142203 — Atricure Cryo Module System; cryoICE cryoablation probe
- K142441 — cryoICE croablation probe
- K142120 — ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
- K140058 — ATRICURE CRYO MODULE SYSTEM
- K131107 — ATRICLIP GILLINOV-COSGROVE LAA CLIP
- K130521 — ISOLATOR LINEAR PEN
- K122611 — COOLRAIL LINEAR PEN MODEL MCRI
- K122276 — ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
- K121507 — ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)
- K112072 — ATRICURE CRYO MODULE SYSTEM
- K111020 — ATRICURE DISSECTOR
- K111042 — ATRICURE CRYO MODULE
- K110117 — ATRICURE BIPOLAR SYSTEM
- K101174 — ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2
- K100501 — MULTIFUNCTIONAL LINEAR PEN
- K093679 — ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0
- K082074 — ATRICURE CRYO1 CRYO-ABLATION PROBE
- K073605 — ATRICURE COOLRAIL LINEAR PEN
- K043579 — ATRICURE BIPOLAR SYSTEM
- K063630 — ATRICURE ABLATION SYSTEM
- K061593 — ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
- K052893 — ATRICURE TRANSPOLAR SYSTEM
- K050459 — ATRICURE ISOLATOR TRANSPOLAR PEN
- K041681 — ATRICURE DISSECTOR
- K020919 — ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1
- K011722 — ATRICURE BIPOLAR COAGULATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.