K141965 is an FDA 510(k) clearance for the PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT. 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 July 2, 2015, 346 days after receiving the submission on July 21, 2014.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.5050.
| 510(k) Number | K141965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2014 |
| Decision Date | July 02, 2015 |
| Days to Decision | 346 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 |