K180846 is an FDA 510(k) clearance for the Arterial Pressure Monitoring Set/Tray. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on December 19, 2018, 261 days after receiving the submission on April 2, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K180846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | April 02, 2018 |
| Decision Date | December 19, 2018 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |