The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System (red 68 Reperfusion Catheter).
| Device ID | K211411 |
| 510k Number | K211411 |
| Device Name: | Penumbra System (RED 68 Reperfusion Catheter) |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 95132 |
| Contact | Micaela Victoria |
| Correspondent | Micaela Victoria Penumbra, Inc. One Penumbra Place Alameda, CA 95132 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-06 |
| Decision Date | 2021-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815948024120 | K211411 | 000 |
| 00815948024113 | K211411 | 000 |
| 00815948024106 | K211411 | 000 |
| 00815948024090 | K211411 | 000 |
| 00815948023901 | K211411 | 000 |
| 00815948023895 | K211411 | 000 |
| 00815948023888 | K211411 | 000 |
| 00815948023871 | K211411 | 000 |
| 00815948024137 | K211411 | 000 |