PLEURX PLEURAL CATHETER AND DRAINAGE KITS
Device Facts
| Record ID | K010642 |
|---|---|
| Device Name | PLEURX PLEURAL CATHETER AND DRAINAGE KITS |
| Applicant | Denver Biomedicals, Inc. |
| Product Code | DWM · Cardiovascular |
| Decision Date | Mar 20, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5050 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.