DELTA-FLOW— 510(k) K780479

Substantially Equivalent

Tri-Delta Intl.

FDA 510(k) clearance K780479 for DELTA-FLOW, Substantially Equivalent on 1978-11-22. Applicant: Tri-Delta Intl..

Clearance details

Applicant: Tri-Delta Intl.
Product code: Code KRA
Advisory panel: Cardiovascular
Date received: 1978-03-27
Decision date: 1978-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.