The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System Ace 68 Reperfusion Catheter.
| Device ID | K161064 |
| 510k Number | K161064 |
| Device Name: | Penumbra System ACE 68 Reperfusion Catheter |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Charles Denault |
| Correspondent | Charles Denault 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 | 2016-04-15 |
| Decision Date | 2016-06-12 |
| Summary: | summary |