DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE— 510(k) K051084
Substantially EquivalentDenver Biomedicals, Inc.
FDA 510(k) clearance K051084 for DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE, Substantially Equivalent on 2005-06-13. 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
- Special
- Location
- Golden, CO, US
Recent devices under product code DWM
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- 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.