510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K102420Substantially Equivalent

Embol-X Access Device/ Aortic Cannula, Embol-X Slim Accessdevice/ Aortic Cannula, Embol-X Glide Access Device/ Aortic Ca

Edwards Lifesciences LLC, Draper UT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102420 is the FDA 510(k) clearance record for EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA, a class II device, cleared for Edwards Lifesciences, LLC on under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). FDA records list 165 510(k) clearances for Edwards Lifesciences, LLC, from to . As of , FDA records show one recall naming K102420.

Clearance record

Decision date
Received
(62 days to decision)
Product code
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Regulation
21 CFR 870.4210
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesciences, LLC 12050 Lone Peak Pkwy., Draper UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWF

Trailing 12 months
8 clearances under product code DWF in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DWF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20262
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20261