The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister.
| Device ID | K180105 |
| 510k Number | K180105 |
| Device Name: | Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-16 |
| Decision Date | 2018-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548019703 | K180105 | 000 |
| 00814548019765 | K180105 | 000 |