The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System (penumbra Jet 7 Reperfusion Catheter With Xtra Flex Technology; Penumbra Jet 7max).
| Device ID | K202251 |
| 510k Number | K202251 |
| Device Name: | Penumbra System (Penumbra JET 7 Reperfusion Catheter With Xtra Flex Technology; Penumbra JET 7MAX) |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Anush Puvvada |
| Correspondent | Anush Puvvada Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-10 |
| Decision Date | 2020-08-31 |
| Summary: | summary |