The following data is part of a premarket notification filed by Edwards Lifesciences Llc with the FDA for Intraclude Intra-aortic Occlusion Device.
| Device ID | K163693 |
| 510k Number | K163693 |
| Device Name: | IntraClude Intra-Aortic Occlusion Device |
| Classification | Clamp, Vascular |
| Applicant | Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 |
| Contact | Lisa G. Hessabi |
| Correspondent | Lisa G. Hessabi Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-28 |
| Decision Date | 2017-01-26 |
| Summary: | summary |