The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Indigo Aspiration System Lightning Aspiration Tubing.
| Device ID | K200771 |
| 510k Number | K200771 |
| Device Name: | Indigo Aspiration System Lightning Aspiration Tubing |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Micaela Victoria |
| Correspondent | Micaela Victoria Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Product Code | QEW |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-25 |
| Decision Date | 2020-04-22 |