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510(k) K234125

AtriClip FLEX-Mini LAA Exclusion System (ACHM) by AtriCure, Inc. — Product Code PZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2024
Date Received
December 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Left Atrial Appendage Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
CV
Submission Type

Intended to occlude the left atrial appendage.

Other clearances by AtriCure, Inc.

  • K252056 — Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (July 24, 2025)
  • K250371 — cryoICE cryoXT cryoablation probe (cryoXT) (April 10, 2025)
  • K243860 — AtriClip PRO-Mini LAA Exclusion System (PROM) (January 15, 2025)
  • K243157 — AtriCure cryoICE BOX (ACM) (October 29, 2024)
  • K234151 — Isolator Synergy EnCapture Ablation System (EMH) (August 27, 2024)
  • K233959 — EPi-Ease Epicardial Access Device (EAS) (February 13, 2024)
  • K233407 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); Atri (November 2, 2023)
  • K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablatio (October 26, 2023)
  • K221358 — Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® L (December 30, 2022)
  • K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE (July 26, 2021)

Other clearances for product code PZX

  • K243860 — AtriClip PRO-Mini LAA Exclusion System (PROM) (January 15, 2025)
  • K233407 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); Atri (November 2, 2023)
  • K232295 — LAA Exclusion System (August 30, 2023)
  • K220305 — Syntheon LAA Exclusion System, Syntheon LAA Selection Guide (October 28, 2022)
  • K210293 — AtriClip LAA Exclusion System (March 3, 2021)
  • K191413 — AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LA (August 21, 2019)
  • K181474 — ArtiClip LAA Exclusion System (June 28, 2018)