DLC 500, DOUBLE LUMEN CATHETER— 510(k) K781050

Substantially Equivalent

Hemodialysis, Division of The

FDA 510(k) clearance K781050 for DLC 500, DOUBLE LUMEN CATHETER, Substantially Equivalent on 1978-09-26. Applicant: Hemodialysis, Division of The.

Clearance details

Applicant: Hemodialysis, Division of The
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1978-06-21
Decision date: 1978-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.