RINSE BLOCK ASSEM, D-W PERI. DIALYSIS— 510(k) K771484

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K771484 for RINSE BLOCK ASSEM, D-W PERI. DIALYSIS, Substantially Equivalent on 1977-10-25. Applicant: Quinton, Inc..

Clearance details

Applicant: Quinton, Inc.
Product code: Code FKX
Advisory panel: Gastroenterology, Urology
Date received: 1977-08-04
Decision date: 1977-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FKX

product code FKX

Death: 501
Injury: 6,720
Malfunction: 18,508
Other: 1
Total: 25,730

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.