The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Aspiration System.
| Device ID | K161506 |
| 510k Number | K161506 |
| Device Name: | Penumbra Aspiration System |
| Classification | Catheter, Embolectomy |
| Applicant | Penumbra, Inc. 1 Penumbra Place Alameda, CA 94502 |
| Contact | Richard Kimura |
| Correspondent | Richard Kimura Penumbra, Inc. 1 Penumbra Place Alameda, CA 94502 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2016-09-26 |
| Summary: | summary |