The following data is part of a premarket notification filed by Denver Biomedical, Inc. with the FDA for Denver Ascites Shunt And Percutaneous Access Kit With Ascities Shunt.
| Device ID | K011862 |
| 510k Number | K011862 |
| Device Name: | DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT |
| Classification | Shunt, Peritoneal |
| Applicant | DENVER BIOMEDICAL, INC. 14998 WEST 6TH AVE., BLDG.E700 Golden, CO 80401 |
| Contact | Bonnie B Vivian |
| Correspondent | Bonnie B Vivian DENVER BIOMEDICAL, INC. 14998 WEST 6TH AVE., BLDG.E700 Golden, CO 80401 |
| Product Code | KPM |
| CFR Regulation Number | 876.5955 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-14 |
| Decision Date | 2001-07-12 |
| Summary: | summary |