The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Indigo Aspiration System.
| Device ID | K163618 |
| 510k Number | K163618 |
| Device Name: | INDIGO 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 | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-22 |
| Decision Date | 2017-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548017594 | K163618 | 000 |
| 00814548017587 | K163618 | 000 |
| 00814548017556 | K163618 | 000 |