FREEDOM SET II WITH TRIFLEX VALVE— 510(k) K870626

Substantially Equivalent

Delmed, Inc.

FDA 510(k) clearance K870626 for FREEDOM SET II WITH TRIFLEX VALVE, Substantially Equivalent on 1987-06-03. Applicant: Delmed, Inc..

Clearance details

Applicant: Delmed, Inc.
Product code: Code KDJ
Advisory panel: Gastroenterology, Urology
Date received: 1987-02-13
Decision date: 1987-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freehold, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDJ

product code KDJ

Death: 298
Injury: 9,221
Malfunction: 8,438
Other: 1
Total: 17,958

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.