The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Reuter Tip Deflecting Wire Guide.
| Device ID | K180830 |
| 510k Number | K180830 |
| Device Name: | Reuter Tip Deflecting Wire Guide |
| Classification | Wire, Guide, Catheter |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Contact | Jennifer L. Allman |
| Correspondent | Jennifer Allman Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-30 |
| Decision Date | 2018-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002086487 | K180830 | 000 |
| 00827002078390 | K180830 | 000 |
| 00827002077829 | K180830 | 000 |