The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Port Access Systems Endodirect Arterial Cannula Model Ed24 (old Code Was-dfk24).
| Device ID | K093730 |
| 510k Number | K093730 |
| Device Name: | PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24) |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | EDWARDS LIFESCIENCES, LLC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | Spencer Walker |
| Correspondent | Spencer Walker EDWARDS LIFESCIENCES, LLC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-03 |
| Decision Date | 2010-01-14 |
| Summary: | summary |