The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Indigo Aspiration System (cat Rx And Separator 4)- Penumbra Engine Pump; Indigo Aspiration System (cat Rx And Separator 4)- Penumbra Engine Pump Canister.
| Device ID | K180412 |
| 510k Number | K180412 |
| Device Name: | Indigo Aspiration System (CAT RX And Separator 4)- Penumbra Engine Pump; Indigo Aspiration System (CAT RX And Separator 4)- Penumbra Engine Pump Canister |
| Classification | Catheter, Embolectomy |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Richard Kimura |
| Correspondent | Michaela Mahl 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 | 2018-02-15 |
| Decision Date | 2018-05-15 |
| Summary: | summary |