RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT— 510(k) K852749

Substantially Equivalent

Mesa Medical, Inc.

FDA 510(k) clearance K852749 for RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT, Substantially Equivalent on 1985-09-10. Applicant: Mesa Medical, Inc..

Clearance details

Applicant: Mesa Medical, Inc.
Product code: Code FKQ
Advisory panel: Gastroenterology, Urology
Date received: 1985-06-27
Decision date: 1985-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FKQ

product code FKQ

Other: 1
Total: 1

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.