The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System (reperfusion Catheter Red 62).
| Device ID | K203440 |
| 510k Number | K203440 |
| Device Name: | Penumbra System (Reperfusion Catheter RED 62) |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Aditi Kolla |
| Correspondent | Aditi Kolla Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-23 |
| Decision Date | 2021-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815948023536 | K203440 | 000 |
| 00815948023475 | K203440 | 000 |