The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7.
| Device ID | K210083 |
| 510k Number | K210083 |
| Device Name: | Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| 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 | QEW |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-12 |
| Decision Date | 2021-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815948024014 | K210083 | 000 |
| 00815948023994 | K210083 | 000 |
| 00815948023970 | K210083 | 000 |
| 00815948022584 | K210083 | 000 |
| 00815948021709 | K210083 | 000 |
| 00815948021716 | K210083 | 000 |
| 00815948021693 | K210083 | 000 |