FDA 510(k) Applications Submitted by Denise Aycox
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K230402 | 02/15/2023 | ENROUTE« Transcarotid Neuroprotection System | Silk Road Medical |
| K190464 | 02/26/2019 | Penumbra System 3D Revascularization Device | Penumbra, Inc. |
| K221414 | 05/16/2022 | ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter | Silk Road Medical, Inc. |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact