510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K244046Substantially Equivalent

Edwards eSheath Optima introducer set

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

K244046 is the FDA 510(k) clearance record for Edwards eSheath Optima introducer set, a class II device, cleared for Edwards Lifesciences on under FDA product code DYB (Introducer, Catheter). FDA records list 165 510(k) clearances for Edwards Lifesciences, from to . As of , FDA records show no recalls naming K244046.

Clearance record

Decision date
Received
(87 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesciences One Edwards Way, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DYB

Trailing 12 months
18 clearances under product code DYB in the twelve months to October 2026, April 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code DYB, trailing twelve months
MonthClearances
November 20250
December 20252
January 20261
February 20262
March 20261
April 20267
May 20260
June 20263
July 20262
August 20260
September 20260
October 20260