TUNNELER— 510(k) K943968
Substantially EquivalentDenver Biomedicals, Inc.
FDA 510(k) clearance K943968 for TUNNELER, Substantially Equivalent on 1995-03-01. Applicant: Denver Biomedicals, Inc.. Device class: 1.
Clearance details
- Applicant
- Denver Biomedicals, Inc.
- Product code
- Code MDM
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Evergreen, CO, US
Recent devices under product code MDM
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- K011020 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
- K010642 — PLEURX PLEURAL CATHETER AND DRAINAGE KITS
- K003451 — DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T
- K913728 — DENVER(R) PERITONEO-SUBCLAVIAN SHUNT
Adverse events under product code MDM
product code MDM- Injury
- 247
- Malfunction
- 1,516
- Total
- 1,763
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.