PLEURX PLEURAL CATHETER AND DRAINAGE KITS— 510(k) K010642
Substantially EquivalentDenver Biomedicals, Inc.
FDA 510(k) clearance K010642 for PLEURX PLEURAL CATHETER AND DRAINAGE KITS, Substantially Equivalent on 2001-03-20. Applicant: Denver Biomedicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Denver Biomedicals, 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
- Traditional
- Location
- Golden, CO, US
Recent devices under product code DWM
view allMore clearances from Denver Biomedicals, Inc.
view all- K051084 — DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE
- K011020 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
- K003451 — DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T
- K943968 — TUNNELER
- K913728 — DENVER(R) PERITONEO-SUBCLAVIAN SHUNT
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.