The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System / Penumbra System Max.
| Device ID | K133317 |
| 510k Number | K133317 |
| Device Name: | PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX |
| Classification | Catheter, Thrombus Retriever |
| Applicant | PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda, CA 94502 |
| Contact | Seth Schulman |
| Correspondent | Seth Schulman PENUMBRA, INC. 1351 HARBOR BAY PKWY. 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 | 2013-10-28 |
| Decision Date | 2014-05-13 |
| Summary: | summary |