K160450 is an FDA 510(k) clearance for the Pleurx Pleural Catheter System. This device is classified as a Apparatus, Suction, Patient Care (Class II - Special Controls, product code DWM).
Submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on October 31, 2016, 256 days after receiving the submission on February 18, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.5050.
| 510(k) Number | K160450 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2016 |
| Decision Date | October 31, 2016 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DWM — Apparatus, Suction, Patient Care |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5050 |