The following data is part of a premarket notification filed by Inneuroco Inc. with the FDA for 074 Zenith Flex System.
| Device ID | K181354 |
| 510k Number | K181354 |
| Device Name: | 074 Zenith Flex System |
| Classification | Catheter, Thrombus Retriever |
| Applicant | InNeuroCo Inc. 4635 NW 103rd Avenue Sunrise, FL 33315 |
| Contact | Marc Litzenberg |
| Correspondent | Marianne Grunwaldt InNeuroCo Inc. 4635 NW 103rd Avenue Sunrise, FL 33351 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-22 |
| Decision Date | 2018-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327459265 | K181354 | 000 |
| 07613327459258 | K181354 | 000 |
| 07613327459241 | K181354 | 000 |