Denver Biomedical, Inc.
Golden, CO, US
Denver Biomedical, Inc. appears in FDA device records in Golden, CO. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Denver Biomedical, Inc. between 2001 and 2005. The busiest year on record is 2001, with 3. The most recent is 2005, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 3 |
| 2005 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K051711 | PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS | PNG | Substantially Equivalent | |
| K052436 | PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 | DWM | Substantially Equivalent | |
| K012235 | DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | KPM | Substantially Equivalent | |
| K011862 | DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT | KPM | Substantially Equivalent | |
| K011831 | MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS | DWM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain