The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System Reperfusion Catheter Jet 7.
| Device ID | K173761 |
| 510k Number | K173761 |
| Device Name: | Penumbra System Reperfusion Catheter JET 7 |
| Classification | Catheter, Thrombus Retriever |
| Applicant | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 |
| Contact | Michaela Mahl |
| Correspondent | Michaela Mahl 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 | 2017-12-11 |
| Decision Date | 2018-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548019918 | K173761 | 000 |
| 00815948023208 | K173761 | 000 |
| 00815948023215 | K173761 | 000 |
| 00815948023222 | K173761 | 000 |
| 00815948023239 | K173761 | 000 |
| 00815948023246 | K173761 | 000 |
| 00814548019819 | K173761 | 000 |
| 00814548019826 | K173761 | 000 |
| 00814548019833 | K173761 | 000 |
| 00814548019840 | K173761 | 000 |
| 00814548019857 | K173761 | 000 |
| 00814548019925 | K173761 | 000 |
| 00814548019864 | K173761 | 000 |
| 00814548019871 | K173761 | 000 |
| 00814548019888 | K173761 | 000 |
| 00814548019895 | K173761 | 000 |
| 00814548019901 | K173761 | 000 |
| 00815948023192 | K173761 | 000 |