K010642 is an FDA 510(k) clearance for the PLEURX PLEURAL CATHETER AND DRAINAGE KITS. This device is classified as a Apparatus, Suction, Patient Care (Class II - Special Controls, product code DWM).
Submitted by Denver Biomedicals, Inc. (Golden, US). The FDA issued a Cleared decision on March 20, 2001, 15 days after receiving the submission on March 5, 2001.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.5050.
| 510(k) Number | K010642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2001 |
| Decision Date | March 20, 2001 |
| Days to Decision | 15 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 |