510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K254232Substantially Equivalent

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)

Edwards Lifesciences LLC, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K254232 is the FDA 510(k) clearance record for 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), a class II device, cleared for Edwards Lifesciences on under FDA product code PZX (Left Atrial Appendage Clip, Implantable). FDA's definition for product code PZX reads: "Intended to occlude the left atrial appendage". FDA records list 165 510(k) clearances for Edwards Lifesciences, from to . As of , FDA records show no recalls naming K254232.

Clearance record

Decision date
Received
(179 days to decision)
Product code
PZX Left Atrial Appendage Clip, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Edwards Lifesciences 1 Edwards Way, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZX

Trailing 12 months
2 clearances under product code PZX in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PZX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260