Remunity 2.0 Pump for Remodulin (treprostinil) Injection— 510(k) K241736
Substantially EquivalentDeka Research and Development Corp.
FDA 510(k) clearance K241736 for Remunity 2.0 Pump for Remodulin (treprostinil) Injection, Substantially Equivalent on 2025-01-16. Applicant: Deka Research and Development Corp..
Clearance details
- Applicant
- Deka Research and Development Corp.
- Product code
- Code FRN
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Manchester, NH, US
Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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.