The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Ferm-flex And Fem-flex Ii ( Femoral Access Arterial Cannulae) Femtrak,vfem, And Fem-flexii.
| Device ID | K140208 |
| 510k Number | K140208 |
| Device Name: | FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Contact | Lindsay Martin |
| Correspondent | Lindsay Martin EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-28 |
| Decision Date | 2014-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103180138 | K140208 | 000 |
| 00690103031287 | K140208 | 000 |
| 00690103031256 | K140208 | 000 |
| 00690103031232 | K140208 | 000 |
| 00690103031218 | K140208 | 000 |
| 00690103031195 | K140208 | 000 |
| 00690103031171 | K140208 | 000 |
| 00690103031157 | K140208 | 000 |
| 00690103031133 | K140208 | 000 |
| 00690103031119 | K140208 | 000 |
| 00690103031096 | K140208 | 000 |
| 00690103031072 | K140208 | 000 |
| 00690103031058 | K140208 | 000 |
| 00690103031034 | K140208 | 000 |
| 00690103031010 | K140208 | 000 |
| 00690103030990 | K140208 | 000 |
| 00690103032444 | K140208 | 000 |
| 00690103032451 | K140208 | 000 |
| 00690103033250 | K140208 | 000 |
| 00690103180121 | K140208 | 000 |
| 00690103168365 | K140208 | 000 |
| 00690103168358 | K140208 | 000 |
| 00690103168341 | K140208 | 000 |
| 00690103146776 | K140208 | 000 |
| 00690103146684 | K140208 | 000 |
| 00690103146677 | K140208 | 000 |
| 00690103146660 | K140208 | 000 |
| 00690103146653 | K140208 | 000 |
| 00690103146646 | K140208 | 000 |
| 00690103041774 | K140208 | 000 |
| 00690103041767 | K140208 | 000 |
| 00690103041743 | K140208 | 000 |
| 00690103041736 | K140208 | 000 |
| 00690103033267 | K140208 | 000 |
| 00690103026849 | K140208 | 000 |