The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System Penumbra Jet 7x.
| Device ID | K191946 |
| 510k Number | K191946 |
| Device Name: | Penumbra System Penumbra JET 7X |
| 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 | 2019-07-22 |
| Decision Date | 2020-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815948021273 | K191946 | 000 |
| 00815948021266 | K191946 | 000 |
| 00815948023284 | K191946 | 000 |
| 00815948023260 | K191946 | 000 |