The following data is part of a premarket notification filed by Denver Biomedicals, Inc. with the FDA for Pleurx Pleural Catheter And Drainage Kits.
| Device ID | K010642 |
| 510k Number | K010642 |
| Device Name: | PLEURX PLEURAL CATHETER AND DRAINAGE KITS |
| Classification | Apparatus, Suction, Patient Care |
| Applicant | DENVER BIOMEDICALS, INC. 14998 W. 6TH AVE., BLDG. E700 Golden, CO 80401 |
| Contact | Nancy Sauer |
| Correspondent | Nancy Sauer DENVER BIOMEDICALS, INC. 14998 W. 6TH AVE., BLDG. E700 Golden, CO 80401 |
| Product Code | DWM |
| CFR Regulation Number | 870.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-05 |
| Decision Date | 2001-03-20 |