The following data is part of a premarket notification filed by Denver Biomedical, Inc. with the FDA for Pleurx Pleural Catheter Kit, Model 50-7000.
| Device ID | K052436 |
| 510k Number | K052436 |
| Device Name: | PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 |
| Classification | Apparatus, Suction, Patient Care |
| Applicant | DENVER BIOMEDICAL, INC. 14998 WEST 6TH AVE., BLDG.E700 Golden, CO 80401 |
| Contact | Jeff Hill |
| Correspondent | Jeff Hill DENVER BIOMEDICAL, INC. 14998 WEST 6TH AVE., BLDG.E700 Golden, CO 80401 |
| Product Code | DWM |
| CFR Regulation Number | 870.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-06 |
| Decision Date | 2005-10-06 |
| Summary: | summary |