The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra 3d Revascularization Device.
| Device ID | K162901 |
| 510k Number | K162901 |
| Device Name: | Penumbra 3D Revascularization Device |
| 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 | 2016-10-17 |
| Decision Date | 2017-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548017853 | K162901 | 000 |
| 00814548017839 | K162901 | 000 |