The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Indigo Aspiration System.
| Device ID | K161523 |
| 510k Number | K161523 |
| Device Name: | INDIGO Aspiration System |
| Classification | Catheter, Embolectomy |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Aditi Kolla |
| Correspondent | Aditi Kolla Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-02 |
| Decision Date | 2016-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548017600 | K161523 | 000 |