The following data is part of a premarket notification filed by Penumbra, Inc with the FDA for Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12.
| Device ID | K192981 |
| 510k Number | K192981 |
| Device Name: | Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 |
| 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 | 2019-10-24 |
| Decision Date | 2020-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815948021556 | K192981 | 000 |
| 00815948021433 | K192981 | 000 |
| 00815948021426 | K192981 | 000 |
| 00815948022935 | K192981 | 000 |
| 00815948022928 | K192981 | 000 |
| 00815948022911 | K192981 | 000 |
| 00815948022904 | K192981 | 000 |
| 00815948022591 | K192981 | 000 |
| 00815948022577 | K192981 | 000 |
| 00815948022560 | K192981 | 000 |
| 00815948021440 | K192981 | 000 |
| 00815948021457 | K192981 | 000 |
| 00815948021549 | K192981 | 000 |
| 00815948021532 | K192981 | 000 |
| 00815948021525 | K192981 | 000 |
| 00815948021518 | K192981 | 000 |
| 00815948021501 | K192981 | 000 |
| 00815948021495 | K192981 | 000 |
| 00815948021488 | K192981 | 000 |
| 00815948021471 | K192981 | 000 |
| 00815948021464 | K192981 | 000 |
| 00815948022553 | K192981 | 000 |