K112831 is an FDA 510(k) clearance for the PLEURX PLEURAL CATHETER SYSTEMS. This device is classified as a Apparatus, Suction, Patient Care (Class II - Special Controls, product code DWM).
Submitted by Care Fusion (Waukegan, US). The FDA issued a Cleared decision on February 16, 2012, 141 days after receiving the submission on September 28, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.5050.
| 510(k) Number | K112831 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2011 |
| Decision Date | February 16, 2012 |
| Days to Decision | 141 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 |