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510(k) K220305

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide by Syntheon — Product Code PZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2022
Date Received
February 2, 2022
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 Syntheon

  • K232295 — LAA Exclusion System (August 30, 2023)
  • 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)
  • K232295 — LAA Exclusion System (August 30, 2023)
  • 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)