The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Penumbra System 110 Aspiration Tubing.
| Device ID | K151623 |
| 510k Number | K151623 |
| Device Name: | Penumbra System 110 Aspiration Tubing |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-16 |
| Decision Date | 2015-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548010397 | K151623 | 000 |
| 00815948020146 | K151623 | 000 |
| 00814548016238 | K151623 | 000 |