PLEURX PLEURAL CATHETER KIT, MODEL 50-7000— 510(k) K052436
Substantially EquivalentDenver Biomedical, Inc.
FDA 510(k) clearance K052436 for PLEURX PLEURAL CATHETER KIT, MODEL 50-7000, Substantially Equivalent on 2005-10-06. Applicant: Denver Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Denver Biomedical, Inc.
- Product code
- Code DWM
- Device class
- Class 2
- Regulation
- 21 CFR 870.5050
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Golden, CO, US
Recent devices under product code DWM
view allMore clearances from Denver Biomedical, Inc.
view all- K051711 — PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
- K012235 — DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
- K011862 — DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
- K011831 — MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS
Adverse events under product code DWM
product code DWM- Death
- 8
- Total
- 8
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.