Atlas FDA

LAA Exclusion System

FDA 510(k) clearance K232295 · decided 2023-08-30

Clearance details

K-number
K232295
Device name
LAA Exclusion System
Applicant
Syntheon, LLC
Decision
Substantially Equivalent
Date received
2023-08-01
Decision date
2023-08-30
Days to decision
29 days
Clearance type
Special
Product code
PZX
Device class
2
Regulation number
878.4300
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Miami, FL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) (K254232)Edwards Lifesciences2026-06-26
ATLAAS (Atraumatic Left Atrial Appendage System) (AD) (K252917)Genesee Biomedical, Inc.2026-05-22
AtriClip PRO-Mini LAA Exclusion System (PROM) (K243860)AtriCure, Inc.2025-01-15
AtriClip FLEX-Mini LAA Exclusion System (ACHM) (K234125)AtriCure, Inc.2024-07-29
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) (K233407)AtriCure, Inc.2023-11-02
Syntheon LAA Exclusion System, Syntheon LAA Selection Guide (K220305)Syntheon2022-10-28
AtriClip LAA Exclusion System (K210293)AtriCure, Inc.2021-03-03
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip (K191413)AtriCure, Inc.2019-08-21
ArtiClip LAA Exclusion System (K181474)AtriCure, Inc.2018-06-28

Recalls involving this device

No recalls on record reference this clearance.