Denver Biomedicals, Inc.
Golden, CO, US
Denver Biomedicals, Inc. appears in FDA device records in Golden, CO. FDA records list 10 510(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
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Denver Biomedicals, Inc. between 1981 and 2005. The busiest year on record is 2001, with 3. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1982 | 1 |
| 1984 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 2001 | 3 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K051084 | DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE | DWM | Substantially Equivalent | |
| K011020 | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | KPM | Substantially Equivalent | |
| K010642 | PLEURX PLEURAL CATHETER AND DRAINAGE KITS | DWM | Substantially Equivalent | |
| K003451 | DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T | KPM | Substantially Equivalent | |
| K943968 | TUNNELER | MDM | Substantially Equivalent | |
| K913728 | DENVER(R) PERITONEO-SUBCLAVIAN SHUNT | KPM | Substantially Equivalent | |
| K842139 | THE DENVER PLEURAL-PERITONEAL SHUNT | KPM | Substantially Equivalent | |
| K822686 | DENVER PERITONEO-VENOUS SHUNT (DP-VS) | KPM | Substantially Equivalent | |
| K811577 | CROUCH CORNEAL PROTECTOR | HOY | Substantially Equivalent | |
| K811183 | DENVER PERITONEO-VENOUS SHUNT | KPM | 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
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Denver Biomedicals, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Denver Biomedicals, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain