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510(k) K252917

ATLAAS (Atraumatic Left Atrial Appendage System) (AD) by Genesee Biomedical, Inc. — Product Code PZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2026
Date Received
September 12, 2025
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.

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  • K202253 — TruForm Sievers Annuloplasty Ring (October 6, 2020)
  • K190506 — NeoForm Annuloplasty Ring (April 18, 2019)
  • K161815 — FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band (October 12, 2016)
  • K093903 — ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC (July 15, 2010)
  • K090428 — ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC (May 7, 2009)
  • K083683 — ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC (February 25, 2009)
  • K072655 — ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR (October 23, 2007)

Other clearances for product code PZX

  • K243860 — AtriClip PRO-Mini LAA Exclusion System (PROM) (January 15, 2025)
  • K234125 — AtriClip FLEX-Mini LAA Exclusion System (ACHM) (July 29, 2024)
  • 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)