The following data is part of a premarket notification filed by Denver Biomedical, Inc. with the FDA for Pleurx Peritoneal Catheter Kit And Pleurx Drainage Kits.
| Device ID | K051711 |
| 510k Number | K051711 |
| Device Name: | PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS |
| Classification | Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling |
| Applicant | DENVER BIOMEDICAL, INC. 433 PARK POINT DR. SUITE 140 Golden, CO 80401 |
| Contact | Nancy Sauer |
| Correspondent | Nancy Sauer DENVER BIOMEDICAL, INC. 433 PARK POINT DR. SUITE 140 Golden, CO 80401 |
| Product Code | PNG |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-27 |
| Decision Date | 2005-11-15 |
| Summary: | summary |