The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System, Penumbra Pump Max.
| Device ID | K160449 |
| 510k Number | K160449 |
| Device Name: | Penumbra System, Penumbra Pump MAX |
| Classification | Catheter, Thrombus Retriever |
| Applicant | PENUMBRA, INC. ONE PENUMBRA PLACE Alameda, CA 94502 |
| Contact | Richard Kimura |
| Correspondent | Richard Kimura 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 | 2016-02-18 |
| Decision Date | 2016-05-25 |
| Summary: | summary |