EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA— 510(k) K123370

Clearance details

Applicant

Edwards Lifesciences, LLC

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

2012-11-01

Decision date

2013-03-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Draper, UT, US

• K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23
• K250937 — Venous Return Cannulae2026-03-11
• K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)2026-02-23
• K253203 — Retrograde Coronary Sinus Perfusion Cannulae2026-02-19
• K253671 — Dual Stage Venous Cannulae2026-01-30

• K251326 — Respiration Rate algorithm2026-06-11
• K253186 — HemoSphere Nano Monitor (HSNANO1)2026-02-24
• K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900)2025-09-23
• K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450)2025-09-17
• K242518 — Hypertension Prediction Index (HePI) Algorithm2025-05-15

Death

106

Injury

386

Malfunction

2,323

Total

2,815

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0420-2020 — EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA (00690103714418), EZF21A (00690103175080), EZF21TA (00690103175097), EZF24A (00690103175066), EZF24TA (00690103175073), EZS21A (00690103172096), EZS21TA (00690103172102), EZS24A (00690103172119), and EZS24TA (00690103172126) Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patient populations.Class II·Terminated·Edwards Lifesciences, LLC·20191022
• Z-3027-2018 — Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.Class II·Terminated·SPS Sterilization, Inc·20180307
• Z-3028-2018 — Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.Class II·Terminated·SPS Sterilization, Inc·20180307
• Z-0134-2014 — Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.Class II·Terminated·Edwards Lifesciences, LLC·20130826

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123370.