ACKRAD FLUID CONNECTING SET— 510(k) K820937

Substantially Equivalent

Ackrad Laboratories

FDA 510(k) clearance K820937 for ACKRAD FLUID CONNECTING SET, Substantially Equivalent on 1982-04-26. Applicant: Ackrad Laboratories.

Clearance details

Applicant: Ackrad Laboratories
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1982-04-05
Decision date: 1982-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.