The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Indigo Aspiration System.
| Device ID | K192833 |
| 510k Number | K192833 |
| Device Name: | Indigo Aspiration System |
| Classification | Catheter, Embolectomy |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Teri Nguyen |
| Correspondent | Teri Nguyen 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 | 2019-10-02 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815948022508 | K192833 | 000 |
| 00815948022980 | K192833 | 000 |
| 00815948023734 | K192833 | 000 |
| 00815948023741 | K192833 | 000 |
| 00815948023758 | K192833 | 000 |
| 00815948022263 | K192833 | 000 |
| 00815948022294 | K192833 | 000 |
| 00815948022324 | K192833 | 000 |
| 00815948022348 | K192833 | 000 |
| 00815948022423 | K192833 | 000 |
| 00815948022430 | K192833 | 000 |
| 00815948022447 | K192833 | 000 |
| 00815948022454 | K192833 | 000 |
| 00815948022461 | K192833 | 000 |
| 00815948022478 | K192833 | 000 |
| 00815948022485 | K192833 | 000 |
| 00815948022492 | K192833 | 000 |
| 00815948024328 | K192833 | 000 |