CATHETER, KIDNEY DIALYSIS, HEMO-CATH II— 510(k) K770552

Substantially Equivalent

Medical Disposables Intl., Inc.

FDA 510(k) clearance K770552 for CATHETER, KIDNEY DIALYSIS, HEMO-CATH II, Substantially Equivalent on 1977-03-30. Applicant: Medical Disposables Intl., Inc..

Clearance details

Applicant: Medical Disposables Intl., Inc.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1977-03-21
Decision date: 1977-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.