FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII— 510(k) K140208

Clearance details

Applicant

Edwards Lifesciences, LLC

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

2014-01-28

Decision date

2014-03-05

Decision

Substantially Equivalent

Clearance type

Special

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-2082-2025 — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: NoClass I·Ongoing·Edwards Lifesciences, LLC·20250514
• Z-2083-2025 — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: NoClass I·Ongoing·Edwards Lifesciences, LLC·20250514
• Z-2084-2025 — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: NoClass I·Ongoing·Edwards Lifesciences, LLC·20250514
• Z-2085-2025 — Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: NoClass I·Ongoing·Edwards Lifesciences, LLC·20250514
• Z-3032-2018 — Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.Class II·Terminated·SPS Sterilization, Inc·20180307
• Z-3033-2018 — Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.Class II·Terminated·SPS Sterilization, Inc·20180307
• Z-1371-2015 — Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures.Class II·Terminated·Edwards Lifesciences, LLC·20150323

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140208.