UNI-PICC— 510(k) K130034
Substantially EquivalentHealth Line International Corporation
FDA 510(k) clearance K130034 for UNI-PICC, Substantially Equivalent on 2013-03-08. Applicant: Health Line International Corporation.
Clearance details
- Applicant
- Health Line International Corporation
- Product code
- Code LJS
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Centerville, UT, 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.