Remunity Pump for Remodulin (treprostinil) Injection— 510(k) K202690

Substantially Equivalent

Deka Research and Development

FDA 510(k) clearance K202690 for Remunity Pump for Remodulin (treprostinil) Injection, Substantially Equivalent on 2020-12-30. Applicant: Deka Research and Development.

Clearance details

Applicant: Deka Research and Development
Product code: Code QJY
Advisory panel: General Hospital
Date received: 2020-09-15
Decision date: 2020-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QJY

product code QJY

Death: 4
Other: 1
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.