The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System (modified 110 Aspiration Tubing).
| Device ID | K182522 |
| 510k Number | K182522 |
| Device Name: | Penumbra System (Modified 110 Aspiration Tubing) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-13 |
| Decision Date | 2018-10-12 |
| Summary: | summary |