The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System Reperfusion Catheter Jet 7.
| Device ID | K190010 |
| 510k Number | K190010 |
| Device Name: | Penumbra System Reperfusion Catheter JET 7 |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Micaela Victoria |
| Correspondent | Micaela Victoria 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 | 2019-01-03 |
| Decision Date | 2019-06-16 |