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510(k) K232295

LAA Exclusion System by Syntheon, LLC — Product Code PZX

K232295 is an FDA 510(k) premarket notification submitted by Syntheon, LLC for the device "LAA Exclusion System". The FDA issued a decision of Substantially Equivalent on August 30, 2023. The device falls under product code PZX (Left Atrial Appendage Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Syntheon, LLC has at least 2 other 510(k) clearances on record.

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

  • K254232 — ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial A (June 26, 2026)
  • K252917 — ATLAAS (Atraumatic Left Atrial Appendage System) (AD) (May 22, 2026)
  • 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)

FDA data resources