The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular Grafts, Stepped Vascular Grafts.
| Device ID | K032900 |
| 510k Number | K032900 |
| Device Name: | LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Daun Putnam |
| Correspondent | Daun Putnam EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-17 |
| Decision Date | 2003-12-04 |
| Summary: | summary |