The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System Ace 64 And Ace 68 Reperfusion Catheters.
| Device ID | K152541 |
| 510k Number | K152541 |
| Device Name: | Penumbra System ACE 64 And ACE 68 Reperfusion Catheters |
| Classification | Catheter, Thrombus Retriever |
| Applicant | PENUMBRA, INC. ONE PENUMBRA PLACE Alameda, CA 94502 |
| Contact | Michaela Mahl |
| Correspondent | Michaela Mahl 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 | 2015-09-04 |
| Decision Date | 2016-01-13 |
| Summary: | summary |