HOLLOW FIBER DIALYZER, BIO CARE PS 130— 510(k) K900018

Substantially Equivalent

National Medical Care, Medical Products Div., Inc.

FDA 510(k) clearance K900018 for HOLLOW FIBER DIALYZER, BIO CARE PS 130, Substantially Equivalent on 1990-07-27. Applicant: National Medical Care, Medical Products Div., Inc..

Clearance details

Applicant: National Medical Care, Medical Products Div., Inc.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 1990-01-02
Decision date: 1990-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, NJ, US

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Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.