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 | K193244 |
| 510k Number | K193244 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-25 |
| Decision Date | 2020-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815948022546 | K193244 | 000 |
| 00815948022539 | K193244 | 000 |
| 00815948023291 | K193244 | 000 |