The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System 3d Revascularization Device.
| Device ID | K190464 |
| 510k Number | K190464 |
| Device Name: | Penumbra System 3D Revascularization Device |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Denise Aycox |
| Correspondent | Denise Aycox Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-26 |
| Decision Date | 2019-04-26 |