The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Lifesciences Percutaneous Sheath Introducers With Oligon Material.
| Device ID | K030944 |
| 510k Number | K030944 |
| Device Name: | EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-26 |
| Decision Date | 2003-06-20 |
| Summary: | summary |