PERITONEAL DIALYSIS CATHETER— 510(k) K771555

Substantially Equivalent

Fluoro-Mold Co.

FDA 510(k) clearance K771555 for PERITONEAL DIALYSIS CATHETER, Substantially Equivalent on 1977-11-28. Applicant: Fluoro-Mold Co..

Clearance details

Applicant: Fluoro-Mold Co.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 1977-08-12
Decision date: 1977-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FJS

product code FJS

Death: 34
Injury: 652
Malfunction: 576
Other: 6
Total: 1,268

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.