The following data is part of a premarket notification filed by Inneuroco, Inc with the FDA for 065 Zenith, 074 Zenith.
| Device ID | K171672 |
| 510k Number | K171672 |
| Device Name: | 065 Zenith, 074 Zenith |
| Classification | Catheter, Percutaneous |
| Applicant | InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, FL 33351 |
| Contact | Marc Litzenberg |
| Correspondent | Marianne Grunwaldt InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, FL 33351 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-06 |
| Decision Date | 2017-10-19 |
| Summary: | summary |