The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Lifesciences Venous Return Cannulae.
| Device ID | K092509 |
| 510k Number | K092509 |
| Device Name: | EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE |
| 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 | 2009-08-17 |
| Decision Date | 2009-10-08 |
| Summary: | summary |