Denver Biomedical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K051711PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITSNovember 15, 2005
K052436PLEURX PLEURAL CATHETER KIT, MODEL 50-7000October 6, 2005
K012235DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBEROctober 4, 2001
K011862DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNTJuly 12, 2001
K011831MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITSJune 28, 2001