Unity Subcutaneous Infusion System for Remodulin— 510(k) K191313
Substantially EquivalentDEKA Research & Development
FDA 510(k) clearance K191313 for Unity Subcutaneous Infusion System for Remodulin, Substantially Equivalent on 2020-02-21. Applicant: DEKA Research & Development.
Clearance details
- Applicant
- DEKA Research & Development
- Product code
- Code QJY
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Manchester, NH, US
Adverse events under product code QJY
product code QJY- Death
- 4
- Other
- 1
- Total
- 5
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.