The following data is part of a premarket notification filed by Edwards Lifesciences Llc. with the FDA for Edwards Lifesciences Research Medical Pediatric Venous Return Cannulae.
| Device ID | K033464 |
| 510k Number | K033464 |
| Device Name: | EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | EDWARDS LIFESCIENCES LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Jason Smith |
| Correspondent | Jason Smith EDWARDS LIFESCIENCES LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-10-31 |
| Decision Date | 2004-06-22 |
| Summary: | summary |