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510(k) K232295

LAA Exclusion System by Syntheon, LLC — Product Code PZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2023
Date Received
August 1, 2023
Clearance Type
Special
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 Syntheon, LLC

  • K220305 — Syntheon LAA Exclusion System, Syntheon LAA Selection Guide (October 28, 2022)
  • K080317 — ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPE (April 29, 2008)

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)
  • 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)