The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Axillary Access Arterial Cannula.
| Device ID | K002578 |
| 510k Number | K002578 |
| Device Name: | AXILLARY ACCESS ARTERIAL CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | EDWARDS LIFESCIENCES, LLC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | Karen Jones |
| Correspondent | Karen Jones EDWARDS LIFESCIENCES, LLC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-18 |
| Decision Date | 2002-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103146011 | K002578 | 000 |
| 00690103144987 | K002578 | 000 |