The following data is part of a premarket notification filed by Inneuroco, Inc with the FDA for 046 Zenith Flex.
| Device ID | K190338 |
| 510k Number | K190338 |
| Device Name: | 046 Zenith Flex |
| Classification | Catheter, Thrombus Retriever |
| Applicant | InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, FL 33351 |
| Contact | Marc Litzenberg |
| Correspondent | Marianne Grunwaldt InNeuroCo 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 | 2019-02-14 |
| Decision Date | 2019-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327519389 | K190338 | 000 |
| 07613327519372 | K190338 | 000 |
| 07613327519365 | K190338 | 000 |
| 07613327519358 | K190338 | 000 |