The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Neuron Delivery Catheter 070.
| Device ID | K082290 |
| 510k Number | K082290 |
| Device Name: | NEURON DELIVERY CATHETER 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 | 2008-08-11 |
| Decision Date | 2008-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814548010151 | K082290 | 000 |
| 00814548010052 | K082290 | 000 |
| 00814548010069 | K082290 | 000 |
| 00814548010076 | K082290 | 000 |
| 00814548010083 | K082290 | 000 |
| 00814548010090 | K082290 | 000 |
| 00814548010106 | K082290 | 000 |
| 00814548010113 | K082290 | 000 |
| 00814548010120 | K082290 | 000 |
| 00814548010045 | K082290 | 000 |