K121849 is an FDA 510(k) clearance for the PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE. 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 October 18, 2012, 115 days after receiving the submission on June 25, 2012.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.5050.
| 510(k) Number | K121849 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2012 |
| Decision Date | October 18, 2012 |
| Days to Decision | 115 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 |