The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra Embolectomy Aspiration System (indigotm Aspiration System).
| Device ID | K160533 |
| 510k Number | K160533 |
| Device Name: | Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) |
| Classification | Catheter, Embolectomy |
| Applicant | PENUMBRA, INC. ONE PENUMBRA PLACE Alameda, CA 94502 |
| Contact | Richard Kimura |
| Correspondent | Richard Kimura PENUMBRA, INC. ONE 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 | 2016-02-18 |
| Decision Date | 2016-05-24 |
| Summary: | summary |