The following data is part of a premarket notification filed by Edwards Lifesciences Llc with the FDA for Fem-flex Ii Femoral Arterial Cannula, Fem-flex Ii Femoral Venous Cannula, Femoral Venous Cannula, Femtrak Femoral Venous Cannula.
| Device ID | K200358 |
| 510k Number | K200358 |
| Device Name: | Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 |
| Contact | Anna Califato |
| Correspondent | Anna Califato Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-13 |
| Decision Date | 2020-03-13 |