The following data is part of a premarket notification filed by Inneuroco, Inc. with the FDA for Zenith Flex System.
| Device ID | K172167 |
| 510k Number | K172167 |
| Device Name: | Zenith Flex System |
| Classification | Catheter, Thrombus Retriever |
| 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 | NRY |
| Subsequent Product Code | DTL |
| Subsequent Product Code | DYB |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-18 |
| Decision Date | 2018-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327459296 | K172167 | 000 |
| 07613327459289 | K172167 | 000 |
| 07613327459272 | K172167 | 000 |
| 07613327459234 | K172167 | 000 |
| 07613327459227 | K172167 | 000 |
| 07613327459210 | K172167 | 000 |