The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Lantern Delivery Microcatheter.
| Device ID | K152840 |
| 510k Number | K152840 |
| Device Name: | Lantern Delivery Microcatheter |
| Classification | Catheter, Percutaneous |
| Applicant | PENUMBRA, INC. ONE PENUMBRA PLACE Alameda, CA 94502 |
| Contact | Charles Denault |
| Correspondent | Charles Denault PENUMBRA, INC. ONE PENUMBRA PLACE Alameda, CA 94502 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2015-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548016696 | K152840 | 000 |
| 00815948023017 | K152840 | 000 |
| 00815948023024 | K152840 | 000 |
| 00814548016610 | K152840 | 000 |
| 00814548016627 | K152840 | 000 |
| 00814548016634 | K152840 | 000 |
| 00814548016641 | K152840 | 000 |
| 00814548016658 | K152840 | 000 |
| 00814548016665 | K152840 | 000 |
| 00814548016672 | K152840 | 000 |
| 00814548016689 | K152840 | 000 |
| 00815948023000 | K152840 | 000 |