The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Indigo Aspiration System - Aspiration Catheter 7 And Separator 7.
| Device ID | K193595 |
| 510k Number | K193595 |
| Device Name: | Indigo Aspiration System - Aspiration Catheter 7 And Separator 7 |
| 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 | 2019-12-23 |
| Decision Date | 2020-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815948021655 | K193595 | 000 |
| 00815948021648 | K193595 | 000 |
| 00815948021631 | K193595 | 000 |