NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER— 510(k) K110627
Substantially EquivalentMarvao Medical Devices, Ltd.
FDA 510(k) clearance K110627 for NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER, Substantially Equivalent on 2011-08-12. Applicant: Marvao Medical Devices, Ltd..
Clearance details
- Applicant
- Marvao Medical Devices, Ltd.
- Product code
- Code LJS
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northborough, MA, US
Adverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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.