The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Fem-felx, Fex-flex Ii Femoral Access Cannula With Duraflo Coating.
| Device ID | K123298 |
| 510k Number | K123298 |
| Device Name: | FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Contact | Dannette Crooms |
| Correspondent | Dannette Crooms EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-23 |
| Decision Date | 2013-03-15 |
| Summary: | summary |