The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Arterial Pressure Monitoring Set/tray.
| Device ID | K180846 |
| 510k Number | K180846 |
| Device Name: | Arterial Pressure Monitoring Set/Tray |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Johnathan Liu |
| Correspondent | Johnathan Liu Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-02 |
| Decision Date | 2018-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002584204 | K180846 | 000 |
| 00827002584082 | K180846 | 000 |
| 00827002584075 | K180846 | 000 |
| 00827002584068 | K180846 | 000 |
| 00827002584051 | K180846 | 000 |
| 00827002584044 | K180846 | 000 |
| 00827002584037 | K180846 | 000 |
| 00827002584020 | K180846 | 000 |
| 00827002584013 | K180846 | 000 |
| 00827002584099 | K180846 | 000 |
| 00827002584105 | K180846 | 000 |
| 00827002584112 | K180846 | 000 |
| 00827002584198 | K180846 | 000 |
| 00827002584181 | K180846 | 000 |
| 00827002584174 | K180846 | 000 |
| 00827002584167 | K180846 | 000 |
| 00827002584150 | K180846 | 000 |
| 00827002584143 | K180846 | 000 |
| 00827002584136 | K180846 | 000 |
| 00827002584129 | K180846 | 000 |
| 00827002584006 | K180846 | 000 |