The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Neuron Select Catheter Size 070.
| Device ID | K083125 |
| 510k Number | K083125 |
| Device Name: | NEURON SELECT CATHETER SIZE 070 |
| Classification | Catheter, Percutaneous |
| Applicant | PENUMBRA, INC. 1351 HARBOR BAY PKWY. Alameda, CA 94502 |
| Contact | Theresa Brandner-allen |
| Correspondent | Theresa Brandner-allen PENUMBRA, INC. 1351 HARBOR BAY PKWY. 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 | 2008-10-22 |
| Decision Date | 2008-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548010236 | K083125 | 000 |
| 00815948027886 | K083125 | 000 |
| 00815948027893 | K083125 | 000 |
| 00815948027909 | K083125 | 000 |
| 00815948027916 | K083125 | 000 |
| 00815948027923 | K083125 | 000 |
| 00814548010182 | K083125 | 000 |
| 00814548010199 | K083125 | 000 |
| 00814548010205 | K083125 | 000 |
| 00814548010212 | K083125 | 000 |
| 00814548010229 | K083125 | 000 |
| 00815948027879 | K083125 | 000 |